Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: mitomycin C
* Drug: tretinoin
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: mitomycin C|nan|
|Drug: tretinoin|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer