Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
Detailed description
OBJECTIVES: * Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma. * Determine the safety of this drug in these patients. OUTLINE: This is an open-label study. Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.
Interventions
DRUGbortezomib
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * Unidimensionally measurable disease * No brain metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 70-100% 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 mg/dL * ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN Other: * No pre-existing neuropathy of grade 1 or greater * No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered * No concurrent biologic therapy Chemotherapy: * No prior cytotoxic therapy * No concurrent cytotoxic therapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No other concurrent anticancer therapy
Countries
United States
Outcome results
None listed