Lung Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Full Description
OBJECTIVES:
Determine the response rate and duration of response to mitomycin, vinorelbine, and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer.
Determine the toxicity of this treatment regimen in these patients.
Determine survival of these patients with this treatment regimen.
OUTLINE: Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8; cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8; and mitomycin IV (courses 1 and 3) on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: At total of 15-46 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage IIIB or IV non-small cell lung cancer
Measurable disease
No brain metastases
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
Zubrod 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute granulocyte count greater than 2,000/mm^3
Platelet count greater than 100,000/mm^3
Hepatic:
Bilirubin less than 2 times upper limit of normal (ULN)
AST and ALT less than 2.5 times ULN (unless attributed to liver metastases)
Renal:
Creatinine no greater than 1.5 mg/dL AND/OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No myocardial infarction within past 6 months
No congestive heart failure
No uncontrolled arrhythmia
Other:
No other concurrent or prior malignancy within past 5 years except localized basal cell or squamous cell skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
At least 4 weeks since prior radiotherapy with clearly progressive disease
Concurrent palliative radiotherapy allowed if no evidence of disease progression
Surgery:
Not specified
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There is 1 Location for this study
Lakewood California, 90712, United States
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