PS-341 in Treating Patients With Metastatic Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of PS-341 in Patients With Renal Cell Cancer|
- Response Rate of PS-341 in colon cancer [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2001|
|Study Completion Date:||March 2006|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
Experimental: Pre-Treatment biopsy followed by PS-341 administration
Pre-treatment tumor biopsy followed by 3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects can continue to receive another 3 cycles of the study drug if their disease has not worsened.
|Drug: PS-341 Procedure: Tumor Biopsy|
Experimental: PS-341 administration followed by biopsy
3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects will have a tumor biopsy and can continue to receive another 3 cycles of the study drug if their disease has not worsened.
|Drug: PS-341 Procedure: Tumor Biopsy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025376
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|Cancer Care Specialists of Central Illinois, S.C.|
|Decatur, Illinois, United States, 62526|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|LaGrange Memorial Hospital|
|LaGrange, Illinois, United States, 60525|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46617|
|United States, Michigan|
|Oncology Care Associates, P.L.L.C.|
|Saint Joseph, Michigan, United States, 49085|
|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|