Spots Global Cancer Trial Database for Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
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Trial Identification
Brief Title: Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
Official Title: Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
Study ID: NCT00068393
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).
Detailed Description: OBJECTIVES: * Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine. * Determine the progression-free survival and overall survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin intravenously (IV) and gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 2- or 3-10 or pegfilgrastim SC on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After 6 courses, patients undergo a MUGA scan. Patients with a stable\* left ventricular ejection fraction (LVEF) continue therapy as above. Patients who reach a total doxorubicin dose of 450 mg/m\^2 and are found to have unstable cardiac function or who have an abnormal LVEF continue therapy with gemcitabine alone. NOTE: \*Stable cardiac function is defined as no decrease more than 15% of LVEF in absolute number and LVEF at least 35% in total function by MUGA. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. ACTUAL ACCRUAL: A total of 39 patients were accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital, Indianapolis, Indiana, United States
Howard Community Hospital at Howard Regional Health System, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Hospital, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York, United States
St. Rita's Medical Center, Lima, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital, Parkersburg, West Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Medical Consultants, Limited, Milwaukee, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Naomi S. Balzer-Haas, MD
Affiliation: Fox Chase Cancer Center
Role: STUDY_CHAIR
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