Kidney Cancer Clinical Trial

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

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).

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA:

Histologically confirmed renal cell carcinoma

Features must be of sarcomatoid histology
Locally recurrent or metastatic disease not amenable to resection
Measurable disease
Must have a prior nephrectomy provided all other eligibility criteria are met, and adequately recovered from any recent surgery
At least 4 weeks since prior radiotherapy and recovered
ECOG performance status of 0-1
WBC greater than 3,000/mm^3 or absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Bilirubin less than 1.5 mg/dL
Aspartate aminotransferase (AST) less than 2 times upper limit of normal
Creatinine no greater than 2.0 mg/dL
LVEF at least lower limit of normal by MUGA
Negative pregnancy test
Fertile patients must use effective contraception
Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer
Age of 18 and over
Diagnostic material from the kidney or metastatic site biopsy available for central pathologic review

EXCLUSION CRITERIA:

Prior treatment for advanced disease
Previously irradiated lesions as the sole site of disease for patients with prior radiation therapy
Concurrent local radiotherapy for pain control or for life-threatening situations
Myocardial infarction within the past year
Congestive heart failure within the past year
Significant ischemic or valvular heart disease within the past year
Prior or concurrent brain metastases
Concurrent serious medical illness that would preclude study treatment
Active infection that would preclude study treatment
Pregnant or nursing

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

39

Study ID:

NCT00068393

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 71 Locations for this study

See Locations Near You

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora Colorado, 80045, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
Mercy Hospital and Medical Center
Chicago Illinois, 60616, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles Illinois, 60714, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie Illinois, 60076, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
William N. Wishard Memorial Hospital
Indianapolis Indiana, 46202, United States
Howard Community Hospital at Howard Regional Health System
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan, 49085, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Great Falls Clinic
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington New Jersey, 08822, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse New York, 13057, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne Pennsylvania, 17043, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53201, United States
Medical Consultants, Limited
Milwaukee Wisconsin, 53215, United States
Marshfield Clinic - Indianhead Center
Rice Lake Wisconsin, 54868, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

39

Study ID:

NCT00068393

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.