Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
3 other identifiers
interventional
39
1 country
92
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2004
Longer than P75 for phase_2
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedStudy Start
First participant enrolled
February 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
January 4, 2013
CompletedJuly 7, 2023
June 1, 2023
5.3 years
September 10, 2003
November 30, 2012
June 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Overall Survival
Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry
Progression-free Survival
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
Study Arms (1)
Doxorubicin/Gemcitabine
EXPERIMENTALDoxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. 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. Cycles were repeated every 2 weeks.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, 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, 60611-3013, 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, 60637-1470, 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, 46202-5289, 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, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, 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, 49007-3731, 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, 59107-5100, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, 59107-7000, 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
Unknown Facility
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, 59807-7877, 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
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, 13057, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, 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, 19111-2497, 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, 57117-5039, 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, 53792-6164, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53201-0342, 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
Related Publications (2)
Haas N, Manola J, Pins M, et al.: ECOG 8802: phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. [Abstract] J Clin Oncol 27 (Suppl 15): A-5038, 2009.
RESULTHaas NB, Lin X, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J. A phase II trial of doxorubicin and gemcitabine in renal cell carcinoma with sarcomatoid features: ECOG 8802. Med Oncol. 2012 Jun;29(2):761-7. doi: 10.1007/s12032-011-9829-8. Epub 2011 Feb 6.
PMID: 21298497RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Naomi S. Balzer-Haas, MD
Fox Chase Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
February 24, 2004
Primary Completion
June 1, 2009
Study Completion
May 1, 2011
Last Updated
July 7, 2023
Results First Posted
January 4, 2013
Record last verified: 2023-06