S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-11-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

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

• Malignant pleural effusion constitutes extensive stage disease

• Must have disease outside area of prior surgical resection or a new lesion must be present

• Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)

• Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

• WBC at least 3,000/mm^3

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

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Not specified

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, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for SCLC

Chemotherapy:

• No prior systemic chemotherapy for SCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy for SCLC except for brain metastases

Surgery:

• See Disease Characteristics

• At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered