Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
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)
1 other identifier
interventional
451
1 country
5
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedFirst Posted
Study publicly available on registry
March 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 25, 2013
October 1, 2013
4.5 years
March 1, 2006
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
1-year
Secondary Outcomes (1)
Objective response
2 cycles
Study Arms (2)
A
ACTIVE COMPARATORChemotherapy (mono)
B
EXPERIMENTALChemotherapy (doublet)
Interventions
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
Eligibility Criteria
You may qualify if:
- Pathologically / cytologically proven NSCLC stage IIIB or IV
- age \>= 70 years old and \< 90 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CH - Pneumologie
Belfort, 90000, France
CHU Besancon - Pneumologie
Besançon, 25000, France
CHU - Pneumologie
Caen, 14000, France
CHU
Grenoble, France
Hôpital Tenon - Pneumologie
Paris, 75020, France
Related Publications (3)
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.
PMID: 17409879BACKGROUNDQuoix 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.
PMID: 21831418RESULTQuoix 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.
PMID: 24114964DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabeth QUOIX, Pr
Intergroupe Francophone de Cancerologie Thoracique
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2006
First Posted
March 2, 2006
Study Start
March 1, 2006
Primary Completion
September 1, 2010
Study Completion
December 1, 2011
Last Updated
October 25, 2013
Record last verified: 2013-10