Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Atrasentan

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