A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
- Compare progression-free and overall survival of patients with advanced metastatic
renal carcinoma treated with interferon alfa with or without interleukin-2 and
- 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
PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Martin E. Gore, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government