Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI); North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Etoposide; Etoposide phosphate; Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically documented extensive stage small cell carcinoma of the bronchus Measurable or evaluable disease No pleural effusions, bone scan abnormalities, or bone marrow biopsies as only evidence of disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-1 Hematopoietic:

Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times normal Renal: Serum creatinine no greater than 1.5 mg/dL Cardiovascular: No cardiac disease Pulmonary: No interstitial pneumonia No fibroid lung Other: Not pregnant or nursing Fertile patients must use effective contraception No psychiatric illness No malabsorption disorder No uncontrolled infection No uncontrolled diabetes mellitus No prior or concurrent malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No chronic steroid therapy (except steroids for adrenal failure or hormones for non-disease related conditions) Radiotherapy: No prior pelvic or mediastinal radiotherapy Surgery: Not specified Other: No concurrent anticonvulsants