search
Back to results

Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
cisplatin
doxorubicin hydrochloride
megestrol acetate
paclitaxel
tamoxifen citrate
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 stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed primary stage III or IV or recurrent endometrial cancer Poor curative potential with radiotherapy or surgery (alone or in combination) Measurable disease At least one lesion accurately measured in at least one dimension At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required ER/PR status of measurable tumor optional PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin normal SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL Cardiovascular: LVEF at least 50% No third-degree or complete heart block, unless pacemaker is in place Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion No history of deep venous thrombosis No uncontrolled angina Pulmonary: No history of pulmonary embolus Other: No other malignancy within the past 5 years except nonmelanoma skin cancer No concurrent medical illness that would preclude study No serious uncontrolled infection No serious peripheral neuropathy No circumstances that would preclude study compliance No sensitivity to E. coli-derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization Endocrine therapy: No prior hormonal therapy for endometrial cancer Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine Surgery: See Disease Characteristics Other: Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • Community Hospital of Los Gatos
  • Chao Family Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • Walter Reed Army Medical Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Rush-Presbyterian-St. Luke's Medical Center
  • University of Chicago Cancer Research Center
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center at The University of Iowa
  • Albert B. Chandler Medical Center, University of Kentucky
  • Tufts University School of Medicine
  • University of Massachusetts Memorial Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • University of Mississippi Medical Center
  • Ellis Fischel Cancer Center - Columbia
  • Washington University School of Medicine
  • Cooper Hospital/University Medical Center
  • Cancer Center of Albany Medical Center
  • State University of New York Health Science Center at Brooklyn
  • Roswell Park Cancer Institute
  • Schneider Children's Hospital at North Shore
  • Memorial Sloan-Kettering Cancer Center
  • State University of New York Health Sciences Center - Stony Brook
  • Lineberger Comprehensive Cancer Center, UNC
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Barrett Cancer Center, The University Hospital
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • University of Oklahoma College of Medicine
  • Abington Memorial Hospital
  • Milton S. Hershey Medical Center
  • University of Pennsylvania Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • Medical University of South Carolina
  • Brookview Research, Inc.
  • Simmons Cancer Center - Dallas
  • M.D. Anderson CCOP Research Base
  • University of Texas - MD Anderson Cancer Center
  • Fletcher Allen Health Care - Medical Center Campus
  • Cancer Center at the University of Virginia
  • Fred Hutchinson Cancer Research Center
  • Tacoma General Hospital
  • Tom Baker Cancer Center - Calgary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
April 10, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00016341
Brief Title
Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
Official Title
Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Study Start Date
May 2001 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in treating endometrial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer.
Detailed Description
OBJECTIVES: Compare the progression-free survival and response of patients with stage III or IV or recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs tamoxifen and megestrol. Compare the survival of patients treated with these regimens. Determine if progesterone receptor status provides information on whether patients are more likely to benefit from chemotherapy. Compare the toxicity profiles of these treatment regimens in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified according to progesterone receptor status (negative vs positive). Patients are randomized to 1 of 2 treatment arms. Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days. Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients cross-over to hormonal therapy as in arm II. Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. At time of disease progression, if patients have not previously been enrolled on arm I, patients cross-over to receive chemotherapy as in arm I. Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6 weeks on cross-over therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
megestrol acetate
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary stage III or IV or recurrent endometrial cancer Poor curative potential with radiotherapy or surgery (alone or in combination) Measurable disease At least one lesion accurately measured in at least one dimension At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required ER/PR status of measurable tumor optional PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin normal SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL Cardiovascular: LVEF at least 50% No third-degree or complete heart block, unless pacemaker is in place Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion No history of deep venous thrombosis No uncontrolled angina Pulmonary: No history of pulmonary embolus Other: No other malignancy within the past 5 years except nonmelanoma skin cancer No concurrent medical illness that would preclude study No serious uncontrolled infection No serious peripheral neuropathy No circumstances that would preclude study compliance No sensitivity to E. coli-derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization Endocrine therapy: No prior hormonal therapy for endometrial cancer Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine Surgery: See Disease Characteristics Other: Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D. Bloss, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
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
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
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
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
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
State University of New York Health Science Center at Brooklyn
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
Schneider Children's Hospital at North Shore
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
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - 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
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
M.D. Anderson CCOP Research Base
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center 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
Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

We'll reach out to this number within 24 hrs