Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Trans Retinoic Acid (Vesanoid) With Chemotherapy in 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Raghu Nandan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Raghu Nandan, M.D., Inc
Authority:
United States: Federal Government
Study ID:
CDR0000067837
NCT ID:
NCT00005825
Start Date:
September 1998
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Rajendra Prasad M.D., Inc. | Lakewood, California 90712 |
