Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

• ClinicalTrials.gov Identifier: NCT00298415
• Recruitment Status: Completed
• First Posted: March 2, 2006
• Last Update Posted: October 25, 2013
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Information provided by (Responsible Party): Intergroupe Francophone de Cancerologie Thoracique

Tracking Information

• First Submitted Date: March 1, 2006
• First Posted Date: March 2, 2006
• Last Update Posted Date: October 25, 2013
• Study Start Date: March 2006
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 27, 2008): Overall survival [ Time Frame: 1-year ]
• Original Primary Outcome Measures (submitted: March 1, 2006): Overall survival
• Current Secondary Outcome Measures (submitted: March 27, 2008): Objective response [ Time Frame: 2 cycles ]
• Original Secondary Outcome Measures (submitted: March 1, 2006): Objective response
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
• Official Title: Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
• Brief Summary: The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)
• Detailed Description: It thus seemed to us justified to compare a standard arm, the vinorelbine or the gemcitabine (with the choice of the center) in monotherapy with an experimental arm, association carboplatine + paclitaxel. To avoid skewing the results by the introduction of a second line to the choice of the investigator, we chose to force it. It is thus the erlotinib which in a recent test presented by the NCIC at the ASCO 2004 proved its effectiveness in second or third line at the same time in term of response but more especially survival compared to the purely palliative care.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: NSCLC

Intervention

• Drug: Paclitaxel + Carboplatin
  Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
  Other Name: Treatment after progression : Erlotinib 150 mg/day
• Drug: Monotherapy (gemcitabine or vinorelbine)
  Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
  Other Name: Treatment after progression : Erlotinib 150mg/day

Study Arms

• Active Comparator: A
  Chemotherapy (mono)
  Intervention: Drug: Monotherapy (gemcitabine or vinorelbine)
• Experimental: B
  Chemotherapy (doublet)
  Intervention: Drug: Paclitaxel + Carboplatin

Publications *

• Pujol JL, Milleron B, Molinier O, Quoix E, Depierre A, Breton JL, Gervais R, Debieuvre D, Hominal S, Namouni F, Tonelli D. Weekly paclitaxel combined with monthly carboplatin in elderly patients with advanced non-small cell lung cancer: a multicenter phase II study. J Thorac Oncol. 2006 May;1(4):328-34.
• Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.
• Quoix E, Westeel V, Moreau L, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Sennelart H, Tredaniel J, Mennecier B, Morin F, Baudrin L, Milleron B, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique. Second-line therapy in elderly patients with advanced nonsmall cell lung cancer. Eur Respir J. 2014 Jan;43(1):240-9. doi: 10.1183/09031936.00048213. Epub 2013 Oct 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 22, 2012): 451
• Original Enrollment (submitted: March 1, 2006): 520
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pathologically / cytologically proven NSCLC stage IIIB or IV
• age >= 70 years old and < 90 years old

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years to 89 Years (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00298415
• Other Study ID Numbers: IFCT-0501
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
• Original Responsible Party: Not Provided
• Current Study Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elisabeth QUOIX, Pr; Intergroupe Francophone de Cancerologie Thoracique

• PRS Account: Intergroupe Francophone de Cancerologie Thoracique
• Verification Date: October 2013