This trial is active, not recruiting.

Condition lung cancer
Treatments cisplatin, mitomycin c, tretinoin, vinorelbine tartrate
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).