Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
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.
Interventional
Primary Purpose: Treatment
Barbara J. Gitlitz, MD
Study Chair
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000069432
NCT00040989
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
University of Rochester Medical Center | Rochester, New York 14642 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Oregon Cancer Institute | Portland, Oregon 97201-3098 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |