Kidney Cancer Clinical Trial
Official title:
A Phase II Trial of PS-341 in Patients With Renal Cell 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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