S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2004-07-01
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Tirapazamine

Criteria

DISEASE CHARACTERISTICS:

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

• No malignant pericardial or pleural effusions, including any of the following:

• Cytologically positive effusions

• Exudative effusions not attributable to other etiologies

• No brain metastases

• Disease (measurable or non-measurable) must be present outside the area of prior surgical resection

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

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

• SGOT or SGPT no greater than 2 times ULN

• Alkaline phosphatase no greater than 2 times ULN

Renal:

• Creatinine no greater than ULN OR

• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No symptomatic sensory neuropathy grade 1 or greater

• No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission

• No other medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for SCLC

Chemotherapy:

• No prior systemic chemotherapy for SCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior thoracic radiotherapy for SCLC

Surgery:

• See Disease Characteristics

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