Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically
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.
Biological: recombinant interferon alfa
Drug: gemcitabine hydrochloride
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||October 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003664
|United States, Indiana|
|Bloomington, Indiana, United States, 47402|
|United States, Nebraska|
|Bergan Mercy Medical Center|
|Omaha, Nebraska, United States, 68124|
|Study Chair:||Gamini S. Soori, MD, FACP, FRCP, MBA||Cancer Biotherapy Research Group|