Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	Other	NANDAN-VES-024 NCI-V00-1587, NCT00005825

Objectives

1. 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.
2. Determine the toxicity of this treatment regimen in these patients.
3. Determine survival of these patients with this treatment regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IIIB or IV non-small cell lung cancer
• Measurable disease
• No brain metastases

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count greater than 2,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

At total of 15-46 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

R. Nandan M.D. Incorporated

Raghu Nandan, MD, Protocol chair		Ph: 562-272-7630 Email: traghu9@hotmail.com

Registry Information
Official Title		Trans Retinoic Acid (Vesanoid) with Chemotherapy in Non-Small Cell Lung Cancer
Trial Start Date		1998-09-01
Registered in ClinicalTrials.gov		NCT00005825
Date Submitted to PDQ		2000-03-29
Information Last Verified		2003-07-23

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