ClinicalTrials.gov

History of Changes for Study: NCT00803062
Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Latest version (submitted July 19, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 4, 2008 None (earliest Version on record)
2 February 6, 2009 Arms and Interventions and Study Status
3 April 3, 2009 Study Status and Eligibility
4 April 14, 2009 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
5 April 26, 2009 Contacts/Locations and Study Status
6 May 7, 2009 Study Status and Contacts/Locations
7 May 13, 2009 Contacts/Locations and Study Status
8 May 19, 2009 Contacts/Locations and Study Status
9 May 21, 2009 Contacts/Locations and Study Status
10 May 23, 2009 Contacts/Locations and Study Status
11 May 28, 2009 Contacts/Locations and Study Status
12 May 30, 2009 Contacts/Locations and Study Status
13 June 2, 2009 Contacts/Locations and Study Status
14 June 3, 2009 Study Status and Contacts/Locations
15 June 5, 2009 Contacts/Locations and Study Status
16 June 10, 2009 Contacts/Locations and Study Status
17 June 11, 2009 Contacts/Locations and Study Status
18 June 12, 2009 Contacts/Locations and Study Status
19 June 17, 2009 Contacts/Locations and Study Status
20 June 19, 2009 Contacts/Locations and Study Status
21 June 20, 2009 Contacts/Locations and Study Status
22 June 23, 2009 Contacts/Locations and Study Status
23 June 26, 2009 Contacts/Locations and Study Status
24 June 30, 2009 Contacts/Locations and Study Status
25 July 2, 2009 Study Status and Contacts/Locations
26 July 4, 2009 Contacts/Locations and Study Status
27 July 7, 2009 Contacts/Locations and Study Status
28 July 10, 2009 Contacts/Locations and Study Status
29 July 11, 2009 Contacts/Locations and Study Status
30 July 14, 2009 Contacts/Locations and Study Status
31 July 20, 2009 Contacts/Locations and Study Status
32 July 21, 2009 Contacts/Locations and Study Status
33 July 22, 2009 Contacts/Locations and Study Status
34 July 24, 2009 Contacts/Locations and Study Status
35 July 28, 2009 Contacts/Locations and Study Status
36 July 29, 2009 Contacts/Locations and Study Status
37 July 30, 2009 Contacts/Locations and Study Status
38 August 1, 2009 Contacts/Locations and Study Status
39 August 5, 2009 Contacts/Locations and Study Status
40 August 7, 2009 Contacts/Locations and Study Status
41 August 8, 2009 Contacts/Locations and Study Status
42 August 13, 2009 Contacts/Locations and Study Status
43 August 14, 2009 Contacts/Locations and Study Status
44 August 16, 2009 Contacts/Locations and Study Status
45 August 19, 2009 Contacts/Locations and Study Status
46 August 20, 2009 Contacts/Locations and Study Status
47 August 21, 2009 Contacts/Locations and Study Status
48 August 25, 2009 Contacts/Locations and Study Status
49 August 27, 2009 Contacts/Locations and Study Status
50 September 2, 2009 Study Status and Contacts/Locations
51 September 11, 2009 Contacts/Locations and Study Status
52 September 12, 2009 Contacts/Locations and Study Status
53 September 16, 2009 Contacts/Locations and Study Status
54 September 17, 2009 Contacts/Locations and Study Status
55 September 29, 2009 Contacts/Locations and Study Status
56 October 1, 2009 Contacts/Locations and Study Status
57 October 2, 2009 Study Status and Contacts/Locations
58 October 3, 2009 Contacts/Locations and Study Status
59 October 8, 2009 Contacts/Locations and Study Status
60 October 13, 2009 Contacts/Locations and Study Status
61 October 15, 2009 Contacts/Locations and Study Status
62 October 16, 2009 Contacts/Locations and Study Status
63 October 17, 2009 Contacts/Locations and Study Status
64 October 29, 2009 Contacts/Locations and Study Status
65 November 3, 2009 Contacts/Locations and Study Status
66 November 4, 2009 Contacts/Locations and Study Status
67 November 5, 2009 Contacts/Locations and Study Status
68 November 10, 2009 Contacts/Locations and Study Status
69 November 12, 2009 Contacts/Locations, Eligibility and Study Status
70 November 16, 2009 Contacts/Locations and Study Status
71 November 17, 2009 Contacts/Locations and Study Status
72 November 18, 2009 Contacts/Locations and Study Status
73 November 25, 2009 Contacts/Locations and Study Status
74 November 26, 2009 Contacts/Locations and Study Status
75 December 11, 2009 Study Status and Contacts/Locations
76 December 13, 2009 Contacts/Locations and Study Status
77 December 15, 2009 Contacts/Locations and Study Status
78 December 16, 2009 Contacts/Locations and Study Status
79 December 26, 2009 Contacts/Locations and Study Status
80 January 2, 2010 Study Status and Contacts/Locations
81 January 6, 2010 Contacts/Locations and Study Status
82 January 7, 2010 Contacts/Locations and Study Status
83 January 8, 2010 Contacts/Locations and Study Status
84 January 9, 2010 Contacts/Locations and Study Status
85 January 13, 2010 Contacts/Locations and Study Status
86 January 15, 2010 Contacts/Locations and Study Status
87 January 19, 2010 Contacts/Locations and Study Status
88 January 26, 2010 Contacts/Locations and Study Status
89 January 27, 2010 Contacts/Locations and Study Status
90 January 28, 2010 Contacts/Locations and Study Status
91 February 2, 2010 Contacts/Locations and Study Status
92 February 3, 2010 Study Status and Contacts/Locations
93 February 4, 2010 Contacts/Locations and Study Status
94 February 5, 2010 Contacts/Locations and Study Status
95 February 9, 2010 Contacts/Locations and Study Status
96 February 11, 2010 Contacts/Locations and Study Status
97 February 13, 2010 Contacts/Locations and Study Status
98 February 17, 2010 Contacts/Locations and Study Status
99 February 24, 2010 Contacts/Locations and Study Status
100 February 26, 2010 Contacts/Locations and Study Status
101 March 3, 2010 Study Status and Contacts/Locations
102 March 5, 2010 Contacts/Locations and Study Status
103 March 6, 2010 Contacts/Locations and Study Status
104 March 9, 2010 Contacts/Locations and Study Status
105 March 10, 2010 Contacts/Locations and Study Status
106 March 11, 2010 Contacts/Locations and Study Status
107 March 13, 2010 Contacts/Locations and Study Status
108 March 16, 2010 Contacts/Locations and Study Status
109 March 18, 2010 Contacts/Locations and Study Status
110 March 19, 2010 Contacts/Locations and Study Status
111 March 23, 2010 Contacts/Locations and Study Status
112 March 24, 2010 Contacts/Locations and Study Status
113 March 27, 2010 Contacts/Locations and Study Status
114 March 30, 2010 Contacts/Locations and Study Status
115 April 6, 2010 Study Status and Contacts/Locations
116 April 7, 2010 Contacts/Locations and Study Status
117 April 8, 2010 Contacts/Locations and Study Status
118 April 10, 2010 Contacts/Locations and Study Status
119 April 15, 2010 References and Study Status
120 April 16, 2010 Contacts/Locations and Study Status
121 April 17, 2010 Contacts/Locations and Study Status
122 April 21, 2010 Contacts/Locations and Study Status
123 April 22, 2010 Contacts/Locations and Study Status
124 April 23, 2010 Contacts/Locations and Study Status
125 April 24, 2010 Contacts/Locations and Study Status
126 April 30, 2010 Contacts/Locations and Study Status
127 May 5, 2010 Contacts/Locations and Study Status
128 May 7, 2010 Contacts/Locations and Study Status
129 May 8, 2010 Contacts/Locations and Study Status
130 May 11, 2010 Contacts/Locations and Study Status
131 May 12, 2010 Contacts/Locations and Study Status
132 May 13, 2010 Contacts/Locations and Study Status
133 May 14, 2010 Contacts/Locations and Study Status
134 May 18, 2010 Contacts/Locations and Study Status
135 May 20, 2010 Contacts/Locations and Study Status
136 May 21, 2010 Contacts/Locations and Study Status
137 May 22, 2010 Contacts/Locations and Study Status
138 May 25, 2010 Contacts/Locations and Study Status
139 May 26, 2010 Contacts/Locations and Study Status
140 May 28, 2010 Contacts/Locations and Study Status
141 May 29, 2010 Contacts/Locations and Study Status
142 June 2, 2010 Study Status and Contacts/Locations
143 June 5, 2010 Contacts/Locations and Study Status
144 June 8, 2010 Contacts/Locations and Study Status
145 June 9, 2010 Contacts/Locations and Study Status
146 June 10, 2010 Contacts/Locations and Study Status
147 June 11, 2010 Contacts/Locations and Study Status
148 June 12, 2010 Contacts/Locations and Study Status
149 June 15, 2010 Contacts/Locations and Study Status
150 June 16, 2010 Contacts/Locations and Study Status
151 June 19, 2010 Contacts/Locations and Study Status
152 June 22, 2010 Contacts/Locations and Study Status
153 June 23, 2010 Contacts/Locations and Study Status
154 June 24, 2010 Contacts/Locations and Study Status
155 June 29, 2010 Contacts/Locations and Study Status
156 June 30, 2010 Contacts/Locations and Study Status
157 July 2, 2010 Study Status and Contacts/Locations
158 July 3, 2010 Contacts/Locations and Study Status
159 July 7, 2010 Contacts/Locations and Study Status
160 July 8, 2010 Contacts/Locations and Study Status
161 July 9, 2010 Contacts/Locations and Study Status
162 July 10, 2010 Contacts/Locations and Study Status
163 July 14, 2010 Contacts/Locations and Study Status
164 July 21, 2010 Contacts/Locations and Study Status
165 July 22, 2010 Contacts/Locations and Study Status
166 July 23, 2010 Contacts/Locations and Study Status
167 July 27, 2010 Contacts/Locations and Study Status
168 July 28, 2010 Contacts/Locations and Study Status
169 July 30, 2010 Contacts/Locations and Study Status
170 July 31, 2010 Contacts/Locations and Study Status
171 August 3, 2010 Study Status and Contacts/Locations
172 August 4, 2010 Contacts/Locations and Study Status
173 August 5, 2010 Contacts/Locations and Study Status
174 August 6, 2010 Contacts/Locations and Study Status
175 August 10, 2010 Contacts/Locations and Study Status
176 August 12, 2010 Contacts/Locations and Study Status
177 August 14, 2010 Contacts/Locations and Study Status
178 August 17, 2010 Contacts/Locations and Study Status
179 August 19, 2010 Contacts/Locations and Study Status
180 August 21, 2010 Contacts/Locations and Study Status
181 August 24, 2010 Contacts/Locations and Study Status
182 August 26, 2010 Contacts/Locations and Study Status
183 August 27, 2010 Contacts/Locations and Study Status
184 August 29, 2010 Contacts/Locations and Study Status
185 September 3, 2010 Study Status and Contacts/Locations
186 September 7, 2010 Contacts/Locations and Study Status
187 September 10, 2010 Contacts/Locations and Study Status
188 September 11, 2010 Contacts/Locations and Study Status
189 September 15, 2010 Contacts/Locations and Study Status
190 September 16, 2010 Contacts/Locations and Study Status
191 September 18, 2010 Contacts/Locations and Study Status
192 September 21, 2010 Contacts/Locations and Study Status
193 September 22, 2010 Contacts/Locations and Study Status
194 September 23, 2010 Contacts/Locations and Study Status
195 October 6, 2010 Study Status and Contacts/Locations
196 October 19, 2010 Contacts/Locations and Study Status
197 October 23, 2010 Contacts/Locations and Study Status
198 October 26, 2010 Contacts/Locations and Study Status
199 October 27, 2010 Contacts/Locations and Study Status
200 October 28, 2010 Contacts/Locations and Study Status
201 October 29, 2010 Contacts/Locations and Study Status
202 November 3, 2010 Study Status and Contacts/Locations
203 November 5, 2010 Contacts/Locations and Study Status
204 November 9, 2010 Contacts/Locations and Study Status
205 November 10, 2010 Contacts/Locations and Study Status
206 November 11, 2010 Contacts/Locations and Study Status
207 November 20, 2010 Contacts/Locations and Study Status
208 November 23, 2010 Contacts/Locations and Study Status
209 November 24, 2010 Contacts/Locations and Study Status
210 December 7, 2010 Study Status and Contacts/Locations
211 December 8, 2010 Contacts/Locations and Study Status
212 December 9, 2010 Contacts/Locations and Study Status
213 December 10, 2010 Contacts/Locations and Study Status
214 December 11, 2010 Contacts/Locations and Study Status
215 December 15, 2010 Contacts/Locations and Study Status
216 December 17, 2010 Contacts/Locations and Study Status
217 December 21, 2010 Contacts/Locations and Study Status
218 January 6, 2011 Study Status and Contacts/Locations
219 January 8, 2011 Contacts/Locations and Study Status
220 January 12, 2011 Contacts/Locations and Study Status
221 January 22, 2011 Contacts/Locations and Study Status
222 January 26, 2011 Contacts/Locations and Study Status
223 January 27, 2011 Contacts/Locations and Study Status
224 January 29, 2011 Contacts/Locations and Study Status
225 February 1, 2011 Contacts/Locations and Study Status
226 February 2, 2011 Contacts/Locations and Study Status
227 February 3, 2011 Contacts/Locations and Study Status
228 February 4, 2011 Contacts/Locations and Study Status
229 February 5, 2011 Contacts/Locations and Study Status
230 February 9, 2011 Contacts/Locations and Study Status
231 February 10, 2011 Contacts/Locations and Study Status
232 February 15, 2011 Contacts/Locations and Study Status
233 February 18, 2011 Contacts/Locations and Study Status
234 February 19, 2011 Contacts/Locations and Study Status
235 February 23, 2011 Contacts/Locations and Study Status
236 February 24, 2011 Contacts/Locations and Study Status
237 February 25, 2011 Contacts/Locations and Study Status
238 March 1, 2011 Contacts/Locations and Study Status
239 March 2, 2011 Study Status and Contacts/Locations
240 March 3, 2011 Contacts/Locations and Study Status
241 March 5, 2011 Contacts/Locations and Study Status
242 March 8, 2011 Contacts/Locations and Study Status
243 March 9, 2011 Contacts/Locations and Study Status
244 March 10, 2011 Contacts/Locations and Study Status
245 March 11, 2011 Contacts/Locations and Study Status
246 March 15, 2011 Contacts/Locations and Study Status
247 March 18, 2011 Contacts/Locations and Study Status
248 March 23, 2011 Contacts/Locations and Study Status
249 March 24, 2011 Contacts/Locations and Study Status
250 April 1, 2011 Contacts/Locations and Study Status
251 April 2, 2011 Study Status and Contacts/Locations
252 April 5, 2011 Contacts/Locations and Study Status
253 April 6, 2011 Contacts/Locations and Study Status
254 April 7, 2011 Contacts/Locations and Study Status
255 April 8, 2011 Contacts/Locations and Study Status
256 April 9, 2011 Contacts/Locations and Study Status
257 April 13, 2011 Contacts/Locations and Study Status
258 April 14, 2011 Contacts/Locations and Study Status
259 April 15, 2011 Contacts/Locations and Study Status
260 April 16, 2011 Contacts/Locations and Study Status
261 April 19, 2011 Contacts/Locations and Study Status
262 April 21, 2011 Contacts/Locations and Study Status
263 April 22, 2011 Contacts/Locations and Study Status
264 April 26, 2011 Contacts/Locations and Study Status
265 April 28, 2011 Contacts/Locations and Study Status
266 April 29, 2011 Contacts/Locations and Study Status
267 April 30, 2011 Contacts/Locations and Study Status
268 May 3, 2011 Contacts/Locations and Study Status
269 May 5, 2011 Study Status and Contacts/Locations
270 May 6, 2011 Contacts/Locations and Study Status
271 May 7, 2011 Contacts/Locations and Study Status
272 May 10, 2011 Contacts/Locations and Study Status
273 May 13, 2011 Contacts/Locations and Study Status
274 May 14, 2011 Contacts/Locations and Study Status
275 May 17, 2011 Contacts/Locations and Study Status
276 May 19, 2011 Contacts/Locations and Study Status
277 May 20, 2011 Contacts/Locations and Study Status
278 May 25, 2011 Contacts/Locations and Study Status
279 June 2, 2011 Contacts/Locations and Study Status
280 June 4, 2011 Contacts/Locations and Study Status
281 June 8, 2011 Contacts/Locations and Study Status
282 June 9, 2011 Contacts/Locations and Study Status
283 June 21, 2011 Contacts/Locations and Study Status
284 June 23, 2011 Contacts/Locations and Study Status
285 June 25, 2011 Contacts/Locations and Study Status
286 July 1, 2011 Contacts/Locations and Study Status
287 July 2, 2011 Study Status
288 July 6, 2011 Contacts/Locations and Study Status
289 July 7, 2011 Contacts/Locations and Study Status
290 July 13, 2011 Contacts/Locations and Study Status
291 July 21, 2011 Contacts/Locations and Study Status
292 August 3, 2011 Study Status
293 August 4, 2011 Contacts/Locations and Study Status
294 August 6, 2011 Contacts/Locations and Study Status
295 August 10, 2011 Contacts/Locations and Study Status
296 August 12, 2011 Contacts/Locations and Study Status
297 August 18, 2011 Contacts/Locations and Study Status
298 August 19, 2011 Contacts/Locations and Study Status
299 August 23, 2011 Contacts/Locations and Study Status
300 August 24, 2011 Contacts/Locations and Study Status
301 August 26, 2011 Contacts/Locations and Study Status
302 August 27, 2011 Contacts/Locations and Study Status
303 August 30, 2011 Contacts/Locations and Study Status
304 September 1, 2011 Contacts/Locations and Study Status
305 September 8, 2011 Study Status and Contacts/Locations
306 September 9, 2011 Contacts/Locations and Study Status
307 September 14, 2011 Contacts/Locations and Study Status
308 September 16, 2011 Contacts/Locations and Study Status
309 September 17, 2011 Contacts/Locations and Study Status
310 September 20, 2011 Contacts/Locations and Study Status
311 September 22, 2011 Contacts/Locations and Study Status
312 September 24, 2011 Contacts/Locations and Study Status
313 October 1, 2011 Contacts/Locations and Study Status
314 October 6, 2011 Study Status and Contacts/Locations
315 October 11, 2011 Contacts/Locations and Study Status
316 October 20, 2011 Contacts/Locations and Study Status
317 November 1, 2011 Contacts/Locations and Study Status
318 November 2, 2011 Study Status and Contacts/Locations
319 November 4, 2011 Contacts/Locations and Study Status
320 November 8, 2011 Contacts/Locations and Study Status
321 November 9, 2011 Contacts/Locations and Study Status
322 November 12, 2011 Contacts/Locations and Study Status
323 November 16, 2011 Contacts/Locations and Study Status
324 November 19, 2011 Contacts/Locations and Study Status
325 November 22, 2011 Contacts/Locations and Study Status
326 November 23, 2011 Contacts/Locations and Study Status
327 November 24, 2011 Contacts/Locations and Study Status
328 November 26, 2011 Contacts/Locations and Study Status
329 November 29, 2011 Contacts/Locations and Study Status
330 December 1, 2011 Contacts/Locations and Study Status
331 December 2, 2011 Study Status and Contacts/Locations
332 December 7, 2011 Contacts/Locations and Study Status
333 December 13, 2011 Contacts/Locations and Study Status
334 December 14, 2011 Contacts/Locations and Study Status
335 December 16, 2011 Contacts/Locations and Study Status
336 December 17, 2011 Contacts/Locations and Study Status
337 December 20, 2011 Contacts/Locations and Study Status
338 December 21, 2011 Contacts/Locations and Study Status
339 December 22, 2011 Contacts/Locations and Study Status
340 December 24, 2011 Contacts/Locations and Study Status
341 December 29, 2011 Contacts/Locations and Study Status
342 December 21, 2012 Recruitment Status, Contacts/Locations, Sponsor/Collaborators, Outcome Measures, Study Status, Arms and Interventions, Conditions, Study Description, Oversight, Study Identification, References, Eligibility and Study Design
343 March 11, 2013 Contacts/Locations, Arms and Interventions, Study Status, Study Identification, Outcome Measures, Study Description and Oversight
344 March 19, 2014 Contacts/Locations, Study Status, Study Description and Study Identification
345 March 26, 2014 Contacts/Locations and Study Status
346 May 19, 2014 Contacts/Locations and Study Status
347 May 27, 2014 Study Status
348 June 2, 2014 Study Status
349 June 29, 2014 Outcome Measures, Contacts/Locations, Study Identification, Arms and Interventions, Study Description, Study Status, Eligibility and Oversight
350 July 1, 2014 Study Status
351 July 8, 2014 Study Status
352 July 11, 2014 Contacts/Locations and Study Status
353 July 15, 2014 Study Status
354 July 18, 2014 Contacts/Locations and Study Status
355 July 22, 2014 Study Status
356 July 28, 2014 Study Status
357 July 30, 2014 Study Status
358 August 5, 2014 Study Identification, Contacts/Locations, Study Description, Study Status and Oversight
359 August 12, 2014 Study Status
360 August 15, 2014 Study Status
361 August 19, 2014 Contacts/Locations and Study Status
362 August 22, 2014 Contacts/Locations and Study Status
363 August 26, 2014 Contacts/Locations and Study Status
364 September 2, 2014 Study Status
365 September 5, 2014 Contacts/Locations and Study Status
366 September 9, 2014 Study Status and Contacts/Locations
367 September 12, 2014 Contacts/Locations and Study Status
368 September 16, 2014 Study Status
369 September 19, 2014 Contacts/Locations and Study Status
370 September 23, 2014 Study Status
371 September 25, 2014 Study Status
372 September 30, 2014 Contacts/Locations and Study Status
373 October 1, 2014 Study Status
374 October 2, 2014 Contacts/Locations and Study Status
375 October 3, 2014 Study Status
376 October 6, 2014 Study Status
377 October 7, 2014 Study Status
378 October 8, 2014 Study Status
379 October 9, 2014 Study Status
380 October 14, 2014 Study Status
381 October 15, 2014 Contacts/Locations and Study Status
382 October 16, 2014 Study Status
383 October 17, 2014 Study Status
384 October 20, 2014 Contacts/Locations and Study Status
385 October 21, 2014 Study Status
386 October 22, 2014 Study Status
387 October 23, 2014 Contacts/Locations and Study Status
388 October 24, 2014 Study Status
389 October 27, 2014 Study Status
390 October 28, 2014 Study Status
391 October 29, 2014 Contacts/Locations and Study Status
392 October 30, 2014 Contacts/Locations and Study Status
393 October 31, 2014 Contacts/Locations and Study Status
394 November 3, 2014 Study Status
395 November 5, 2014 Contacts/Locations and Study Status
396 November 6, 2014 Study Status
397 November 7, 2014 Study Status
398 November 11, 2014 Study Status
399 November 13, 2014 Study Status
400 November 14, 2014 Study Status
401 November 17, 2014 Contacts/Locations and Study Status
402 November 18, 2014 Study Status
403 November 19, 2014 Contacts/Locations and Study Status
404 November 20, 2014 Study Status
405 November 21, 2014 Arms and Interventions, Conditions and Study Status
406 November 24, 2014 Study Status
407 November 25, 2014 Study Status
408 November 28, 2014 Study Status
409 December 1, 2014 Study Status
410 December 2, 2014 Study Status
411 December 3, 2014 Study Status
412 December 4, 2014 Study Status
413 December 5, 2014 Study Status
414 December 8, 2014 Study Status
415 December 9, 2014 Study Status
416 December 10, 2014 Study Status
417 December 11, 2014 Study Status
418 December 12, 2014 Study Status
419 December 15, 2014 Contacts/Locations and Study Status
420 December 16, 2014 Study Status
421 December 17, 2014 Study Status
422 December 18, 2014 Study Status
423 December 22, 2014 Contacts/Locations and Study Status
424 December 23, 2014 Study Status
425 December 24, 2014 Contacts/Locations and Study Status
426 December 29, 2014 Study Status
427 December 30, 2014 Study Status
428 December 31, 2014 Study Status
429 January 2, 2015 Study Status
430 January 5, 2015 Study Status
431 January 6, 2015 Study Status
432 January 7, 2015 Contacts/Locations and Study Status
433 January 8, 2015 Study Status
434 January 9, 2015 Study Status
435 January 12, 2015 Study Status
436 January 13, 2015 Study Status
437 January 28, 2015 Study Identification, Contacts/Locations, Study Description, Eligibility, Oversight and Study Status
438 January 29, 2015 Study Status
439 January 30, 2015 Study Status
440 February 2, 2015 Study Status
441 February 3, 2015 Study Status
442 February 4, 2015 Contacts/Locations and Study Status
443 February 5, 2015 Study Status
444 February 6, 2015 Study Status
445 February 9, 2015 Study Status
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447 February 11, 2015 Study Status
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450 February 17, 2015 Study Status
451 February 18, 2015 Study Status
452 February 19, 2015 Study Status
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454 February 23, 2015 Study Status
455 February 24, 2015 Study Status
456 February 25, 2015 Study Status
457 February 26, 2015 Study Status
458 February 27, 2015 Study Status
459 March 2, 2015 Study Status
460 May 22, 2015 Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions and Study Design
461 April 15, 2016 Outcome Measures, Study Status, Results, Arms and Interventions and Study Design
462 November 3, 2017 Outcome Measures, Study Status and Contacts/Locations
463 July 19, 2019 Study Status, Contacts/Locations and Sponsor/Collaborators
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Study NCT00803062
Submitted Date:  December 4, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000628746
Brief Title: Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Official Title: A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, In Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
Secondary IDs: GOG-0240
Open or close this module Study Status
Record Verification: December 2008
Overall Status: Not yet recruiting
Study Start: March 2008
Primary Completion: December 2011 [Anticipated]
Study Completion:
First Submitted: December 4, 2008
First Submitted that
Met QC Criteria:
December 4, 2008
First Posted: December 5, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 4, 2008
Last Update Posted: December 5, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gynecologic Oncology Group
Responsible Party:
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.

PURPOSE: This randomized phase III trial is studying the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, recurrent, or persistent cervical cancer.

Detailed Description:

OBJECTIVES:

Primary

  • To compare the overall survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with paclitaxel in combination with cisplatin or topotecan with vs without bevacizumab.
  • To compare the frequency and severity of adverse events associated with these regimens as assessed by NCI CTCAE v3.0.

Secondary

  • To compare the progression-free survival of these patients.
  • To compare the proportion of patients with tumor response.

Tertiary

  • To compare the health-related quality of life as assessed by the FACT-Cx TOI; neuropathy symptoms as assessed by the FACT/GOG-Ntx4 subscale; and pain as assessed by the Brief Pain Inventory in these patients.
  • To evaluate the impact of age, race, performance status, stage, histology, grade, disease site, prior chemoradiotherapy, and time to recurrence on response rate, progression-free survival, and overall survival of these patients.
  • To determine the prevalence of active smoking in these patients.
  • To estimate the extent of tobacco/nicotine dependence in these patients.
  • To determine if smoking is an independent risk factor for progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease status (recurrent/persistent disease vs primary stage IVB disease), GOG performance status (0 vs 1), and prior platinum therapy as a radiosensitizer (yes vs no). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
  • Arm II: Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
  • Arm III: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
  • Arm IV: Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.

In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires, including the FACT-Cx TOI, FACT/GOG-Ntx4, and Brief Pain Inventory, at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. Patients also complete a smoking questionnaire at baseline.

After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Open or close this module Conditions
Conditions: Cervical Cancer
Keywords: cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
recurrent cervical cancer
stage IVB cervical cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Experimental: Arm II
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
Drug: bevacizumab
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Experimental: Arm III
Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
Drug: paclitaxel
Given IV
Drug: topotecan hydrochloride
Given IV
Experimental: Arm IV
Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
Drug: bevacizumab
Given IV
Drug: paclitaxel
Given IV
Drug: topotecan hydrochloride
Given IV
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival
2. Frequency and severity of adverse events as assessed by NCI CTCAE v3.0
Secondary Outcome Measures:
1. Progression-free survival
2. Frequency of objective tumor response
3. Health-related quality of life as assessed by FACT-Cx TOI; neuropathy symptoms as assessed by FACT/GOG-Ntx4 subscale; and pain as assessed by the Brief Pain Inventory at baseline, before courses 2 and 5, and at 6 and 9 months after course 1
4. Impact of age, race, performance status, stage, histology, grade, disease site, prior chemoradiotherapy, and time to recurrence on response rate, progression-free survival, and overall survival
5. Prevalence of active smoking as assessed by the smoking questionnaire at baseline
6. Extent of nicotine dependence as assessed by the smoking questionnaire at baseline
7. Correlation of nicotine dependence with progression-free survival and overall survival
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
    • Squamous cell carcinoma
    • Adenosquamous cell carcinoma
    • Adenocarcinoma
  • Stage IVB, recurrent, or persistent disease not amenable to curative treatment with surgery and/or radiotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
    • Biopsy confirmation required if target lesion(s) measures < 30 mm or if the treating physician determines it is clinically indicated
    • Has ≥ 1 "target lesion" that can be used to assess response
      • Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy
  • No history or evidence of CNS disease, including primary brain tumor, brain metastases, or craniospinal metastases

PATIENT CHARACTERISTICS:

  • GOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times normal
  • SGOT ≤ 3 times normal
  • Alkaline phosphatase ≤ 3 times normal
  • PT/INR ≤ 1.5 (or in-range INR, if patient is on a stable dose of therapeutic warfarin for management of venous thrombosis, including pulmonary thromboembolus)
  • PTT < 1.2 times upper limit of normal
  • Serum creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Urine protein:creatinine ratio 1.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No active infection requiring antibiotics
  • No significant traumatic injury within the past 28 days
  • No serious non-healing wound, ulcer, or bone fracture
    • Patients with granulating incisions healing by secondary intention are eligible provided there is no evidence of fascial dehiscence or infection AND the wound is examined weekly
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3-6 months
    • Patients must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation
  • No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
  • No active bleeding or pathologic condition that carries a high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
  • No seizures not controlled with standard medical therapy
  • No cerebrovascular accident (i.e., stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • No clinically significant cardiovascular disease, including any of the following:
    • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina within the past 6 months
    • NYHA class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
      • Atrial fibrillation allowed provided it is asymptomatic and ventricular rate is controlled
    • Significant peripheral vascular disease (i.e., ≥ grade 2 peripheral vascular disease, as defined by NCI CTCAE v3.0 criteria)
  • No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • No prior anti-cancer therapy that would preclude study therapy
  • No prior anti-VEGF drugs, including bevacizumab
  • No prior chemotherapy unless given concurrently with radiotherapy
  • At least 6 weeks since prior chemoradiotherapy
  • At least 3 weeks since prior radiotherapy alone
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior core biopsy
  • No concurrent major surgery including, but not limited to, abdominal surgery prior to disease progression (e.g., colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second-look surgery via laparotomy or laparoscopy)
Open or close this module Contacts/Locations
Study Officials: Krishnansu Tewari, MD
Principal Investigator
Chao Family Comprehensive Cancer Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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