A Phase 3 interventional study of Paclitaxel + Carboplatin and Monotherapy (gemcitabine or vinorelbine) in NSCLC, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 5 sites in France. Open to participants aged 70 Years to 89 Years. Per ClinicalTrials.gov, last updated 2013-10-25.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 3, Interventional, and Treatment
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)
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 451 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
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Inclusion Criteria:
Chemotherapy (mono)
Drug: Monotherapy (gemcitabine or vinorelbine)
Chemotherapy (doublet)
Drug: Paclitaxel + Carboplatin
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
Also known as: Treatment after progression : Erlotinib 150 mg/day
Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
Also known as: Treatment after progression : Erlotinib 150mg/day
Overall survival
Time frame: 1-year
Objective response
Time frame: 2 cycles
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Intergroupe Francophone de Cancerologie Thoracique