Spots Global Cancer Trial Database for BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
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Trial Identification
Brief Title: BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Official Title: Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
Study ID: NCT00040989
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722. * Determine the duration of response, time to progression, and survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Oncology-Hematology Group of South Florida, Miami, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of Rochester Medical Center, Rochester, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Oregon Cancer Institute, Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
Contact Details
Name: Barbara J. Gitlitz, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: STUDY_CHAIR
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