A Randomized Phase III Comparative Study of Paclitaxel With Carboplatin Versus Mitomycin, Ifosfamide, Cisplatin (MIC) Chemotherapy in Inoperable Advanced Stage Non-Small Cell Lung Cancer
- Compare the one and two year survival of patients with inoperable advanced non-small
cell lung cancer treated with paclitaxel and cisplatin versus standard platinum
- Compare the toxic effects of these two regimens in this patient population.
- Compare the performance status, tumor response, and quality of life in these patients
after these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs
Patients are randomized to one of two treatment arms:
- Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30
minutes on day 1.
- Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV
over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on
Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression
or unacceptable toxicity.
Quality of life is assessed before each treatment course.
Patients are followed for survival.
PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for
Allocation: Randomized, Primary Purpose: Treatment
Nick Thatcher, PhD, FRCP
Christie Hospital NHS Foundation Trust
United States: Federal Government