Kidney Cancer Clinical Trial
Official title:
A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
Prednisone may help to relieve symptoms in patients with recurrent and/or metastatic kidney
cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of
vinorelbine and estramustine with or without prednisone in treating patients who have
recurrent and/or metastatic kidney cancer.
OBJECTIVES: I. Estimate the response rate of vinorelbine and estramustine in patients with
metastatic and/or recurrent renal cell carcinoma. II. Obtain pilot data exploring the value
of anti-inflammatory treatment in the management of severe systemic symptoms and improvement
of treatment tolerance in this patient population.
OUTLINE: Patients are stratified according to number of risk factors (0,1 versus 2 versus
3). Patients receive vinorelbine IV on days 1, 8, 15, 22, 28, and 35. Patients also receive
estramustine orally twice per day on days 1-7 and an increased dose on days 8-42. A tapered
dose of oral prednisone is given to patients with an elevated erythrocyte sedimentation
rate. A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest.
Patients with stable disease may receive up to 4 courses of treatment. Patients who achieve
a partial response may undergo surgical resection followed by up to 2 additional courses of
treatment or an interleukin-2 treatment regimen. Patients with a complete response receive 1
additional course of treatment. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.
;
Primary Purpose: Treatment
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