Trial Information

A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma

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.