OBJECTIVES:

• Determine whether epothilone B can produce a significant response (complete response (CR) or partial response (PR)) as measured by tumor shrinkage in patients with advanced renal cancer.
• Determine the objective response rate and duration of response in patients with CR or PR after treatment with this drug.
• Determine the time to disease progression and overall survival in patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.
• Determine genetic factors related to renal cancer that may predict response in patients treated with this drug.
• Determine relative susceptibility to drug-drug interactions or serious side effects in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive epothilone B IV over 5 minutes once weekly for three weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week and then every three months thereafter.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial renal cell carcinoma

  • Clear cell
  • Sarcomatoid
  • Papillary
  • Medullary
  • Collecting duct
  • Chromophobe
  • Mixed histology
• Progressive regional disease or metastatic disease
• Prior nephrectomy required
• Previously untreated patients or patients who have received no more than one prior cytokine regimen (interleukin-2, interferon alfa, or a combination of these agents) and have failed or relapsed within 8 months of treatment

• At least one measurable lesion

  • Patients who have received prior radiotherapy to the marker lesion(s) must have disease progression in that lesion since treatment
• No CNS metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC greater than 3,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3
• Hemoglobin greater than 9.0 g/dL
• Platelet count greater than 100,000/mm^3
• Red blood cell transfusions allowed

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase less than 2.5 times ULN

Renal:

• Creatinine less than 1.5 times ULN

Cardiovascular:

• No severe cardiac insufficiency
• No New York Heart Association class III or IV disease
• No uncontrolled and/or unstable cardiac or coronary artery disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 6 months after study therapy
• No peripheral neuropathy greater than grade 1
• No unresolved diarrhea greater than grade 1
• No active or suspected acute or chronic uncontrolled infection
• No abscess or fistula
• HIV negative
• No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix
• No prior noncompliance to medical regimens
• No history of severe medical conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery

Other:

• More than 28 days since prior investigational drugs
• No other concurrent investigational drugs
• No concurrent warfarin or other agents containing warfarin except low-dose warfarin (1 mg or less) administered prophylactically for maintenance of indwelling lines or ports