Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||cisplatin, mitomycin c, tretinoin, vinorelbine tartrate|
|Sponsor||Raghu Nandan, M.D., Inc|
|Start date||September 1998|
|Trial identifier||NCT00005825, CDR0000067837, NANDAN-VES-024, NCI-V00-1587|
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.
Male or female participants at least 18 years old.
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
|Official title||Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer|
|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.|
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