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
carboplatin
+ cisplatin
+ ifosfamide
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: 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 therapy. 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 3). 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 day 1. 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 this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed inoperable advanced non-small cell lung cancer Stage IIIA, IIIB, or IV Not eligible for curative radiotherapy or surgery Measurable or evaluable disease No bony lesions as only site of measurable disease No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Other: Not pregnant Fertile patients must use effective contraception during and for 3 months after study No active infection No other serious systemic disorder that would preclude compliance No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Christie Hospital N.H.S. Trust
Manchester, United KingdomOpen Christie Hospital N.H.S. Trust in Google Maps