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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0189 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| cisplatin | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| megestrol acetate | Drug | |||
| paclitaxel | Drug | |||
| tamoxifen citrate | Drug |
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
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D. Bloss, MD | Washington University Siteman Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
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| Jonsson Comprehensive Cancer Center, UCLA |
| Los Angeles |
| California |
| 90095-1781 |
| United States |
| Community Hospital of Los Gatos | Los Gatos | California | 95032 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80010 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City | Iowa | 52242-1009 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103 | United States |
| Cancer Center of Albany Medical Center | Albany | New York | 12208 | United States |
| State University of New York Health Science Center at Brooklyn | Brooklyn | New York | 11203 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Schneider Children's Hospital at North Shore | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-7775 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45267-0502 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Brookview Research, Inc. | Nashville | Tennessee | 37203 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| M.D. Anderson CCOP Research Base | Houston | Texas | 77030-4009 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Fletcher Allen Health Care - Medical Center Campus | Burlington | Vermont | 05401 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Tom Baker Cancer Center - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D019290 | Megestrol Acetate |
| D017239 | Paclitaxel |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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