PS-341 in Treating Patients With Metastatic Kidney Cancer

NCT ID: NCT00025376

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2006-03-31

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PS-341

Intervention Type: DRUG

Tumor Biopsy

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

PS-341

Intervention Type: DRUG

Tumor Biopsy

Intervention Type: PROCEDURE

Interventions

PS-341

Intervention Type: DRUG

Tumor Biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter M. Stadler, MD, FACP

Role: STUDY_CHAIR

University of Chicago

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

LaGrange Memorial Hospital

LaGrange, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Michiana Hematology/Oncology P.C.

South Bend, Indiana, United States

Oncology Care Associates, P.L.L.C.

Saint Joseph, Michigan, United States

Countries

United States

Other Identifiers

UCCRC-11049A

Identifier Type: -

Identifier Source: secondary_id

NCI-3291

Identifier Type: -

Identifier Source: secondary_id

11049A

Identifier Type: -

Identifier Source: org_study_id