PS-341 in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
Information provided by (Responsible Party):
Walter Stadler, University of Chicago
ClinicalTrials.gov Identifier:
NCT00025376
First received: October 11, 2001
Last updated: December 16, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: PS-341 Procedure: Tumor Biopsy |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Response Rate of PS-341 in colon cancer [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | October 2001 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025376
Locations
| 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 | |
Sponsors and Collaborators
University of Chicago
Investigators
| Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter Stadler, Professor, Dir Genitourinary Oncology, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00025376 History of Changes |
| Other Study ID Numbers: | 11049A, UCCRC-11049A, NCI-3291 |
| Study First Received: | October 11, 2001 |
| Last Updated: | December 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013