Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 24, 2004

Primary Completion Date

June 30, 2009

Study Completion Date

May 31, 2011

Conditions
Metastatic Renal Cell CarcinomaRenal Cell Carcinoma With Sarcomatoid Features
Interventions
DRUG

Doxorubicin

Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.

DRUG

Gemcitabine

Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.

DRUG

G-CSF (granulocyte-colony stimulating factor)

Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.

DRUG

Neulasta

Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.

Trial Locations (92)

10466

Our Lady of Mercy Medical Center Comprehensive Cancer Center, The Bronx

13057

CCOP - Hematology-Oncology Associates of Central New York, Syracuse

16803

Mount Nittany Medical Center, State College

17043

Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne

17044

Lewistown Hospital, Lewistown

26102

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital, Parkersburg

45801

St. Rita's Medical Center, Lima

46202

William N. Wishard Memorial Hospital, Indianapolis

46350

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte

46360

Saint Anthony Memorial Health Centers, Michigan City

46515

Elkhart General Hospital, Elkhart

46601

CCOP - Northern Indiana CR Consortium, South Bend

Memorial Hospital of South Bend, South Bend

46617

Saint Joseph Regional Medical Center, South Bend

46904

Howard Community Hospital at Howard Regional Health System, Kokomo

48093

St. John Macomb Hospital, Warren

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

Seton Cancer Institute - Saginaw, Saginaw

48909

Sparrow Regional Cancer Center, Lansing

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49085

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph

49201

Foote Hospital, Jackson

50010

McFarland Clinic, PC, Ames

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

Siouxland Regional Cancer Center, Sioux City

51104

St. Luke's Regional Medical Center, Sioux City

52403

Cedar Rapids Oncology Associates, Cedar Rapids

53215

Medical Consultants, Limited, Milwaukee

54449

Marshfield Clinic - Marshfield Center, Marshfield

54601

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse

54868

Marshfield Clinic - Indianhead Center, Rice Lake

55805

CCOP - Duluth, Duluth

Miller-Dwan Medical Center, Duluth

St. Mary's - Duluth Clinic Cancer Center, Duluth

55905

Mayo Clinic Cancer Center, Rochester

57105

Avera Cancer Institute, Sioux Falls

Medical X-Ray Center, PC, Sioux Falls

59101

CCOP - Montana Cancer Consortium, Billings

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings

Northern Rockies Radiation Oncology Center, Billings

St. Vincent Healthcare, Billings

59405

Great Falls Clinic, Great Falls

Great Falls

59601

St. Peter's Hospital, Helena

59701

St. James Community Hospital, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

59801

Community Medical Center, Missoula

59804

Guardian Oncology and Center for Wellness, Missoula

59807

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula

59901

Glacier Oncology, PLLC, Kalispell

Kalispell Medical Oncology, Kalispell

Kalispell Regional Medical Center, Kalispell

60048

North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville

60076

Hematology Oncology Associates - Skokie, Skokie

Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie

60432

Midwest Center for Hematology/Oncology, Joliet

60435

Joliet Oncology-Hematology Associates, Limited - West, Joliet

60507

Rush-Copley Cancer Care Center, Aurora

60611

Hematology and Oncology Associates, Chicago

Veterans Affairs Medical Center - Lakeside Chicago, Chicago

60616

Mercy Hospital and Medical Center, Chicago

60714

Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles

61801

Carle Cancer Center at Carle Foundation Hospital, Urbana

CCOP - Carle Cancer Center, Urbana

80045

University of Colorado Cancer Center at UC Health Sciences Center, Aurora

82801

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

46202-5289

Indiana University Cancer Center, Indianapolis

02118

Cancer Research Center at Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

48106-0995

Saint Joseph Mercy Cancer Center, Ann Arbor

48123-2500

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49007-3731

West Michigan Cancer Center, Kalamazoo

59107-5100

Billings Clinic Cancer Center, Billings

59107-7000

Deaconess Billings Clinic - Downtown, Billings

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

08822

Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington

07601

CCOP - Northern New Jersey, Hackensack

08903

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick

14263-0001

Roswell Park Cancer Institute, Buffalo

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

57117-5039

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls

53792-6164

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison

53201-0342

Aurora Sinai Medical Center, Milwaukee

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT00068393 - Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma | Biotech Hunter | Biotech Hunter