Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00039429|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: atrasentan hydrochloride||Phase 2|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||April 2006|
- Progression-free survival at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039429
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|Study Chair:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|