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

Sponsor

Raghu Nandan, M.D., Inc (Other)

Overall Status

Unknown status

CT.gov ID

NCT00005825

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: cisplatin Drug: mitomycin C Drug: tretinoin Drug: vinorelbine tartrate	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer

Study Start Date :

Sep 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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