Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer | NCT00039429 | Trialant

Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer | NCT00039429 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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