Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
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.
Interventions
DRUGPS-341
PROCEDURETumor Biopsy
Sponsors
National Cancer Institute (NCI)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of PS-341 in colon cancer | 9 weeks |
Countries
United States
Outcome results
None listed