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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00040989 |
Purpose
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer |
Drug: BAY 56-3722 Procedure: enzyme inhibitor therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Florida | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| United States, Georgia | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08903 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642-0001 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229-3264 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Study Chair: | Barbara J. Gitlitz, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069432, UCLA-0201019, UTHSC-0125011152, BAYER-100364, NCI-G02-2090 |
| Study First Received: | July 8, 2002 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00040989 History of Changes |
| Health Authority: | United States: Federal Government |
|
Disease Attributes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Recurrence Carcinoma |
Neoplasms Pathologic Processes Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |