First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Yonsei University
• Treatments: Carboplatin; Docetaxel; Gemcitabine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven or radiologically and clinically suspected stage IIIB (with malignant pleural effusion) or IV non-small cell lung cancer

• Unresectable disease

• At least 1 measurable lesion (> 10 mm with spiral CT scan or > 20 mm with conventional CT scan)

• No symptomatic or untreated brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy > 12 weeks

• ANC ≥ 1,500/mm³

• Hemoglobin > 9.0 g/dL

• Platelet count ≥ 100,000/mm³

• AST and ALT < 2 times upper limit of normal (ULN)

• Bilirubin < 1.5 mg/dL

• Creatinine < 1.5 times ULN

• Not pregnant or nursing

• No serious uncontrolled systemic intercurrent illness, including any of the following:

• Acute myocardial infarction

• Uncontrolled arrhythmia

• Uncontrolled heart failure

• Sepsis

• Poorly controlled diabetes

• No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior radiotherapy, including cranial irradiation

• At least 3 weeks since prior major surgery

• No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed more than 12 months ago