Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Launched by RAGHU NANDAN, M.D., INC · Jan 26, 2003
Trial Information
Current as of May 20, 2025
Unknown status
Keywords
ClinConnect Summary
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 una...
Gender
ALL
Eligibility 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
About Raghu Nandan, M.D., Inc
Raghu Nandan, M.D., Inc. is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative clinical studies. Led by Dr. Raghu Nandan, a seasoned medical professional with extensive expertise in clinical research, the organization prioritizes rigorous scientific methodologies and ethical standards. Committed to collaboration with healthcare institutions and regulatory bodies, Raghu Nandan, M.D., Inc. aims to facilitate the development of cutting-edge therapies, ensuring that new treatments are both safe and effective for diverse patient populations. Through a patient-centered approach, the organization strives to contribute significantly to the medical field and enhance the quality of care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lakewood, California, United States
Patients applied
Trial Officials
Raghu Nandan, MD
Study Chair
Raghu Nandan, M.D., Inc
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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