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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Nick Thatcher, PhD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000067562
NCT ID:
NCT00004887
Start Date:
January 1999
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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