A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
OBJECTIVES:
- Determine the objective response rate in patients with metastatic renal cell cancer
treated with bortezomib.
- Determine the time to tumor progression and 1-year survival of patients treated with
this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2.
Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients then undergo core biopsy.
- Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.
Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable
disease or a partial or complete response continue to receive bortezomib in the absence of
disease progression or unacceptable toxicity.
Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14
months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate of PS-341 in colon cancer
9 weeks
No
Walter M. Stadler, MD, FACP
Study Chair
University of Chicago
United States: Federal Government
11049A
NCT00025376
October 2001
March 2006
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Oncology Care Associates, P.L.L.C. | Saint Joseph, Michigan 49085 |
LaGrange Memorial Hospital | LaGrange, Illinois 60525 |