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Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01837251
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : July 13, 2021
Sponsor:
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
ARCAGY/ GINECO GROUP
Australia New Zealand Gynaecological Oncology Group
Scottish Gynaecological Cancer Study Group
Information provided by (Responsible Party):
AGO Research GmbH

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE April 23, 2013
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
investigator-determined progression-free survival [ Time Frame: every 12 weeks until progression or up to 30 months (whichever occurs first) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
  • biological progression-free survival by serum CA 125 [ Time Frame: every 3 weeks until progression or up to 30 months (whichever occurs first) ]
  • Health related Quality of Life (QoL) [ Time Frame: Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first) ]
  • Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions [ Time Frame: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later) ]
  • Overall Survival [ Time Frame: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
  • biological progression-free survival by serum CA 125 [ Time Frame: every 3 weeks until progression or up to 30 months (whichever occurs first) ]
  • Health related Quality of Life (QoL) [ Time Frame: Baseline and then every 12 weeks until progresssion, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later) ]
  • Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions [ Time Frame: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later) ]
  • Overall Survival [ Time Frame: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Official Title  ICMJE A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Brief Summary Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Platinum-sensitive Ovarian Cancer
Intervention  ICMJE
  • Drug: Carboplatin
  • Drug: PLD
  • Biological: Bevacizumab
Study Arms  ICMJE
  • No Intervention: Control Arm
    Patients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 & 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
  • Experimental: Research Arm
    Patients receive bevacizumab 10 mg/kg iv on day 1 & 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
    Interventions:
    • Drug: Carboplatin
    • Drug: PLD
    • Biological: Bevacizumab
Publications * Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marme F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16. Erratum In: Lancet Oncol. 2022 Jun;23(6):e248.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
682
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2013)
654
Actual Study Completion Date  ICMJE January 2021
Actual Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma
  2. First disease recurrence >6 months after first-line platinum-based chemotherapy
  3. Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse
  4. In case of cytoreductive surgery for recurrence, patients must be able to commence cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery
  5. ECOG PS 0-2
  6. Absolute Neutrophil Count >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L; Hemoglobin >= 9.5 g/dL
  7. Patients not receiving anticoagulant medication who have an International Normalized Ratio <= 1.5 and an Activated ProThrombin Time <= 1.5 x ULN
  8. Serum bilirubin <= 2 x ULN; Serum transaminases <= 2.5 x ULN (<= 5 x ULN in the presence of liver metastasis)
  9. Serum creatinine < 1.6 mg/dL or creatinine clearance >= 40 mL/min; Glomerular filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula); Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24 hour urine collection must demonstrate <= 1 g of protein in 24 hours
  10. Normal blood pressure or adequately treated and controlled hypertension (either systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg)

Exclusion Criteria:

  1. Ovarian tumors of low malignant potential
  2. Malignancies other than ovarian cancer within 5 years prior to randomization
  3. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period
  4. Any previous radiotherapy to the abdomen or pelvis
  5. Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant human or humanised antibodies
  6. Current or recent chronic use of aspirin > 325 mg/day
  7. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of Bevacizumab
  8. History of VEGF therapy related abdominal fistula or gastrointestinal perforation
  9. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
  10. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  11. Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage
  12. Prior history of hypertensive crisis or hypertensive encephalopathy
  13. Clinically significant disease, including: myocardial infarction or unstable angina within ≤ 6 months of randomization; New York Heart Association (NYHA) >= grade 2 Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication; peripheral vascular disease grade >= 3
  14. LVEF defined by ECHO/MUGA below the institutional lower limit of normal
  15. Significant traumatic injury during 4 weeks prior to randomization
  16. Current brain metastases or spinal cord compression
  17. History or evidence upon neurological examination of central nervous system disease
  18. Non-healing wound, active ulcer or bone fracture
  19. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
  20. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic coagulation)
  21. Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the duration of the trial and at least 6 months afterwards
  22. Pregnant or lactating women
  23. Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging heparin
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   France,   Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837251
Other Study ID Numbers  ICMJE AGO-OVAR 2.21 / ENGOT ov-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AGO Research GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AGO Research GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • ARCAGY/ GINECO GROUP
  • Australia New Zealand Gynaecological Oncology Group
  • Scottish Gynaecological Cancer Study Group
Investigators  ICMJE
Study Chair: Jacobus Pfisterer, PhD MD AGO Study Group
PRS Account AGO Research GmbH
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP