Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer

OBJECTIVES:

• Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.
• Compare the toxicity of these regimens in these patients.
• Assess the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.
• Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.

Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Advanced metastatic disease that requires treatment
• Measurable disease (single bone lesions not included)
• No brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 to 81

Performance status

• WHO 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC greater than 3,000/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin greater than 10 g/dL

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No myocardial infarction within the past 6 months
• No unstable angina pectoris

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for at least 6 months after study participation
• No other concurrent disease or prior malignancy that would preclude study treatments or comparisons
• No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No prior endocrine therapy
• No concurrent corticosteroids

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• Prior resection of the primary tumor recommended but not required
• No prior major organ allografts