Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04). Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04). Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group [specifically patients who have received 1 prior therapy] is the only stratum open for accrual).

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: atrasentan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atrasentan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6 months |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer