A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
18 Years
N/A
Both
Kidney Cancer
Trial Information
A Phase II Trial of PS-341 in Patients With Renal Cell 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate of PS-341 in colon cancer
Outcome Time Frame:
9 weeks
Safety Issue:
No
Principal Investigator
Walter M. Stadler, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
University of Chicago
Authority:
United States: Federal Government
Study ID:
11049A
NCT ID:
NCT00025376
Start Date:
October 2001
Completion Date:
March 2006
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
| Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
| Oncology Care Associates, P.L.L.C. | Saint Joseph, Michigan 49085 |
| LaGrange Memorial Hospital | LaGrange, Illinois 60525 |
