Kidney Cancer Clinical Trial
Official title:
Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to
kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells.
Combining chemotherapy with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and
biological therapy in treating patients with kidney cancer that is metastatic or cannot be
removed surgically.
OBJECTIVES: I. Determine the toxic effects of interferon alfa, interleukin-2, gemcitabine,
and fluorouracil in patients with metastatic or unresectable renal cell cancer. II. Evaluate
the feasibility and possible therapeutic anticancer efficacy of this therapy in these
patients. III. Determine the duration of response, survival, and improvement of quality of
life in these patients.
OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine
IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered
subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is
administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course.
Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic
effects and disease progression. Following chemobiotherapy, maintenance therapy is
administered to patients with stable or responding disease. Patients receive subcutaneous
interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or
for a maximum of 1 year. A quality of life assessment is completed weekly. Patients are
followed until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18-24
months.
;
Primary Purpose: Treatment
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