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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039429 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: atrasentan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma |
| Estimated Enrollment: | 180 |
| Study Start Date: | May 2003 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease, defined by 1 of the following:
One of the following disease characteristics:
At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 177 Study Locations| Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069382, ECOG-E6800 |
| Study First Received: | June 6, 2002 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039429 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |