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Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma Recurrent or persistent disease Refractory to curative or standard therapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan At least 1 target lesion Tumors within a previously irradiated field are not considered target lesions Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction Ineligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age Any age Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGOT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No neuropathy (sensory and motor) ≥ grade 2 No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 3 weeks since prior biologic or immunologic therapy for malignant tumor No concurrent prophylactic growth factors No concurrent prophylactic thrombopoietic agents Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs) Endocrine therapy At least 1 week since prior hormonal therapy for malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics Recovered from prior radiotherapy Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy for malignant tumor No prior anticancer therapy that would preclude current protocol therapy No concurrent amifostine or other protective reagents

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • CCOP - Western Regional, Arizona
  • Jonsson Comprehensive Cancer Center at UCLA
  • Women's Cancer Center - Los Gatos
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Yale Comprehensive Cancer Center
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • MBCCOP - Hawaii
  • Rush University Medical Center
  • MBCCOP - University of Illinois at Chicago
  • University of Chicago Cancer Research Center
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Saint Joseph Regional Medical Center
  • Holden Comprehensive Cancer Center at University of Iowa
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Cancer Center at Tufts - New England Medical Center
  • UMASS Memorial Cancer Center - University Campus
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Grand Rapids
  • CCOP - Kalamazoo
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • University of Mississippi Medical Center
  • Keesler Medical Center - Keesler Air Force Base
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Missouri Valley Cancer Consortium
  • Cancer Institute of New Jersey at the Cooper University Hospital
  • SUNY Downstate Medical Center
  • Roswell Park Cancer Institute
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Long Island Cancer Center at Stony Brook University Hospital
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Duke Comprehensive Cancer Center
  • Gynecologic Oncology Network
  • Comprehensive Cancer Center at Wake Forest University
  • Charles M. Barrett Cancer Center at University Hospital
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • University of Oklahoma College of Medicine
  • CCOP - Columbia River Oncology Program
  • Abington Memorial Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • UPMC Cancer Center at Magee-Womens Hospital
  • Southeast Gynecologic Oncology Associates
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • University of Texas Medical Branch
  • MD Anderson Cancer Center at University of Texas
  • CCOP - Scott and White Hospital
  • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
  • Cancer Center at the University of Virginia
  • Fred Hutchinson Cancer Research Center
  • MultiCare Regional Cancer Center at Tacoma General Hospital
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Australia New Zealand Gynaecological Oncology Trials Group
  • Tom Baker Cancer Centre - Calgary
  • Kagoshima City Hospital
  • Norwegian Radium Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
January 10, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085332
Brief Title
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
Official Title
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).
Detailed Description
OBJECTIVES: Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma Recurrent or persistent disease Refractory to curative or standard therapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan At least 1 target lesion Tumors within a previously irradiated field are not considered target lesions Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction Ineligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age Any age Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGOT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No neuropathy (sensory and motor) ≥ grade 2 No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 3 weeks since prior biologic or immunologic therapy for malignant tumor No concurrent prophylactic growth factors No concurrent prophylactic thrombopoietic agents Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs) Endocrine therapy At least 1 week since prior hormonal therapy for malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics Recovered from prior radiotherapy Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy for malignant tumor No prior anticancer therapy that would preclude current protocol therapy No concurrent amifostine or other protective reagents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia, MD
Organizational Affiliation
Premiere Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1740
Country
United States
Facility Name
Women's Cancer Center - Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3824
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62794-9640
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Cancer Center at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605-2982
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Keesler Medical Center - Keesler Air Force Base
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7570
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Gynecologic Oncology Network
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0520
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Cancer Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3180
Country
United States
Facility Name
Southeast Gynecologic Oncology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2516
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9032
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
MultiCare Regional Cancer Center at Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6188
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Australia New Zealand Gynaecological Oncology Trials Group
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
1450
Country
Australia
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Kagoshima City Hospital
City
Kagoshima City
ZIP/Postal Code
892-8580
Country
Japan
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
18675446
Citation
Garcia AA, Blessing JA, Nolte S, Mannel RS; Gynecologic Oncology Group. A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group. Gynecol Oncol. 2008 Oct;111(1):22-6. doi: 10.1016/j.ygyno.2008.06.013.
Results Reference
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Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

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