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.
- 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
- Histologically confirmed renal cell carcinoma
- Metastatic disease
- Unidimensionally measurable disease
- No brain metastases
- Not specified
- Karnofsky 70-100%
- More than 3 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- ALT/AST no greater than 2.5 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 times ULN
- 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
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after study
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior biologic therapy and recovered
- No concurrent biologic therapy
- No prior cytotoxic therapy
- No concurrent cytotoxic therapy
- Not specified
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- At least 4 weeks since prior major surgery
- No other concurrent anticancer therapy