A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
- 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
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- 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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate of PS-341 in colon cancer
Walter M. Stadler, MD, FACP
University of Chicago
United States: Federal Government
|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|