Dolastatin 10 in Treating Patients With Advanced Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with advanced kidney cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date:||August 1999|
|Study Completion Date:||May 2009|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the response rate to dolastatin 10 in patients with advanced renal cell carcinoma. II. Describe the toxicities of this regimen in this patient population. III. Assess the development of peripheral neuropathy in this patient population using this regimen. IV. Assess a limited sampling of pharmacokinetics and correlate with toxicity in these patients.
OUTLINE: Patients receive dolastatin 10 IV every 3 weeks. Treatment continues for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses, and may receive retreatment at the time of progression at the discretion of the investigator. Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 4-15 months.
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Henry C. Pitot, MD||Mayo Clinic|