Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Inclusion Criteria

• •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