Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen is more effective for non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Unresectable stage IIIB or IV disease

• No untreated brain or leptomeningeal metastases

• Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment

• No symptomatic (i.e., requiring thoracentesis) pleural effusion

• No clinically significant (i.e., grade 3 or greater) pericardial effusion

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 (70 years of age and over) OR

• ECOG 2 (under 70 years of age)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 8.0 g/dL

Hepatic

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR

• Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

• No grade 2 or greater peripheral neuropathy

• No prior hypersensitivity reaction to taxanes or products containing polysorbate 80

• No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer

• No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less)

• No concurrent radiotherapy

Surgery

• More than 3 weeks since prior major surgery

Other

• More than 30 days since prior anticancer investigational drugs

• Concurrent supportive care investigational agents allowed