PS-341 in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: PS-341
* Procedure: Tumor Biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic renal cell cancer Measurable disease At least 2.0 cm in at least 1 dimension by physical exam OR at least 1.0 cm in at least 1 dimension by radiologic exam Single measurable lesion must not be within prior radiotherapy portal Tumor lesion amenable to core biopsy At least 1 cm of tumor obtainable No active CNS metastatic disease Single previously resected CNS metastasis allowed provided no disease progression 8 weeks after therapy and no longer requiring steroids or antiseizure medications PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier-method contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy or biotherapy allowed Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis) Surgery: See Disease Characteristics Other: No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-Treatment biopsy followed by PS-341 administration<br>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<br> <br> Procedure: Tumor Biopsy<br> <br> |
| Experimental: PS-341 administration followed by biopsy<br>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<br> <br> Procedure: Tumor Biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate of PS-341 in colon cancer |  | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer