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

Raghu Nandan, M.D., Inc

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

cisplatinDRUG

mitomycin CDRUG

tretinoinDRUG

vinorelbine tartrateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rajendra Prasad M.D., Inc.

Lakewood, California, United States

Data from ClinicalTrials.gov

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