Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection

• Progressive disease, defined by 1 of the following:

  • The appearance of 1 or more new lesions
  • At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)

• One of the following disease characteristics:

  • Disease manifested solely by bone metastases

  • At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm^3 OR
• Absolute neutrophil count greater than 1,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin less than 1.5 mg/dL
• AST and/or ALT less than 1.5 times upper limit of normal (ULN)

Renal:

• Creatinine less than 1.5 times ULN

Cardiovascular:

• No history of New York Heart Association class II-IV heart disease

Pulmonary:

• No significant pulmonary disease requiring pulse steroid therapy within the past 3 months

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other serious concurrent medical illness that would preclude study participation
• No active infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy/immunotherapy and recovered

• No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)

  • Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered
• Prior radiotherapy for local control or palliation of painful bony lesion allowed
• No prior radiotherapy to target lesions
• No concurrent radiotherapy for palliation or any other indication

Surgery:

• At least 4 weeks since prior surgery and recovered
• Prior nephrectomy allowed

Other:

• Prior bisphosphonates allowed