PS-341 in Treating Patients With Metastatic Kidney Cancer
PS-341 in Treating Patients With Metastatic Kidney Cancer
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.
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.
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