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

NCT ID: NCT00005825

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

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.

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

mitomycin C

Intervention Type: DRUG

tretinoin

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raghu Nandan, M.D., Inc

OTHER

Sponsor Role: lead

Principal Investigators

Raghu Nandan, MD

Role: STUDY_CHAIR

Raghu Nandan, M.D., Inc

Locations

Rajendra Prasad M.D., Inc.

Lakewood, California, United States

Countries

United States

Other Identifiers

NANDAN-VES-024

Identifier Type: -

Identifier Source: secondary_id

NCI-V00-1587

Identifier Type: -

Identifier Source: secondary_id

CDR0000067837

Identifier Type: -

Identifier Source: org_study_id