Spots Global Cancer Trial Database for PS-341 in Treating Patients With Metastatic Kidney Cancer

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Trial Identification

Brief Title: PS-341 in Treating Patients With Metastatic Kidney Cancer

Official Title: A Phase II Trial of PS-341 in Patients With Renal Cell Cancer

Study ID: NCT00025376

Conditions

Kidney Cancer

Interventions

PS-341

Tumor Biopsy

Study Description

Brief Summary: 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.

Detailed Description: 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.