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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005825
• Other study ID #: CDR0000067837
• Secondary ID: NANDAN-VES-024NC
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: December 17, 2013
• Start date: September 1998

Study information

• Verified date: July 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• mitomycin C

• tretinoin

• vinorelbine tartrate

Locations

Country	Name	City	State
United States	Rajendra Prasad M.D., Inc.	Lakewood	California

Sponsors (1)

Lead Sponsor	Collaborator
Raghu Nandan, M.D., Inc

Country where clinical trial is conducted

United States,