S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-12-01
• 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 combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; National Cancer Institute (NCI); North Central Cancer Treatment Group
• Treatments: Camptothecin; Cisplatin; Etoposide; Etoposide phosphate; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)

• Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam

• Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

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

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

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 2.5 times ULN

Renal

• Creatinine normal

• Creatinine clearance at least 50 mL/min

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• HIV negative

• No concurrent AIDS-related illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for SCLC

• No filgrastim (G-CSF) within 24 hours of chemotherapy

Chemotherapy

• No prior systemic chemotherapy for SCLC

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

• At least 21 days since prior brain radiotherapy and recovered

• No other prior radiotherapy for SCLC

Surgery

• See Disease Characteristics

• At least 21 days since prior thoracic or other major surgery and recovered

Other

• No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)