Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma

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