Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer
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.
Drug: estramustine phosphate sodium
Drug: vinorelbine tartrate
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||July 1998|
|Study Completion Date:||December 2000|
|Primary Completion Date:||December 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003584
|United States, New Mexico|
|University of New Mexico Cancer Research & Treatment Center|
|Albuquerque, New Mexico, United States, 87131|
|Study Chair:||Laurence Elias, MD||University of New Mexico Cancer Center|