A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma

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