Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate by Solid Tumor Response Criteria (RECIST)
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry
No
Naomi S. Balzer-Haas, MD
Study Chair
Fox Chase Cancer Center
United States: Food and Drug Administration
CDR0000322258
NCT00068393
December 2003
May 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Duluth | Duluth, Minnesota 55805 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Great Falls Clinic | Great Falls, Montana 59405 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Medical Consultants, Limited | Milwaukee, Wisconsin 53215 |
Aurora Sinai Medical Center | Milwaukee, Wisconsin 53201-0342 |
Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania 17043 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |