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Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer

Phase 3
18 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer


- Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs
carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or
recurrent endometrial cancer.

- Determine whether estrogen/progesterone receptor status provides prognostic information
in patients treated with these regimens.

- Compare the toxicity profile of these regimens, specifically neurotoxicity and
infection, in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients accrued as of 04/17/06 are
stratified according to disease status(measurable or recurrent disease vs non-measurable
stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease
without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients
with LVEF < 50% at randomization who are initially randomized to arm I are immediately
crossed over to arm II.

- Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90
minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF)
subcutaneously on days 3-12.

- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60
minutes on day 1.

In both arms, treatment repeats every 21 days for 7 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this
study within approximately 5 years.

Inclusion Criteria


- Histologically confirmed endometrial carcinoma

- FIGO stage III or IV or recurrent disease

- Must know estrogen and progesterone status of the primary tumor

- Poor potential for curative treatment by radiotherapy and/or surgery

- At least 1 unidimensionally measurable lesion (for patients with stage III disease

- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, or MRI) OR at least 10 mm by spiral CT scan

- Disease in a previously irradiated field acceptable as the only site of
measurable disease only if there has been clear progression since completion of



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- ALT no greater than 3 times upper limit of normal


- Creatinine no greater than 1.6 mg/dL


- LVEF at least 50%

- Cardiac conduction abnormalities or dysfunction allowed at the investigator's

- No third-degree or complete heart block without a pacemaker

- No uncontrolled angina

- No myocardial infarction within the past 6 months

- No New York Heart Association class II -IV heart failure

- No symptoms of congestive heart failure


- Not pregnant or nursing

- Fertile patients must use effective non-hormonal contraception during and for at
least 2 months after study participation

- No other invasive malignancy within the past 5 years except patients who have
nonmelanoma skin cancer or have received prior chemotherapy for that malignancy

- No serious uncontrolled infection

- No serious peripheral neuropathy

- No other concurrent medical illness that would preclude study therapy

- No circumstances that would preclude study completion or follow-up

- No sensitivity to Escherichia coli-derived drug preparations

- No uterine carcinosarcoma or other non-epithelial uterine malignancy


Biologic therapy

- Prior biologic therapy allowed

- No concurrent biologic therapy


- No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or
any other malignancy

Endocrine therapy

- Prior hormonal therapy allowed

- No concurrent hormonal therapy


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the

- No concurrent radiotherapy


- Not specified


- Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers,
or calcium channel blockers) are allowed at the investigator's discretion

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Duration of overall survival

Safety Issue:


Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
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Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
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Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
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Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
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Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
San Francisco General Hospital Medical Center San Francisco, California  94110
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Missouri Baptist Cancer Center St. Louis, Missouri  63131
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Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem, Ohio  44460
Cancer Treatment Center Wooster, Ohio  44691
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
John B. Amos Cancer Center Columbus, Georgia  31904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Frederick R. and Betty M. Smith Cancer Treatment Center Sparta, New Jersey  07871
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
North Coast Cancer Care - Clyde Clyde, Ohio  43410
Hematology Oncology Center Elyria, Ohio  44035
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Clinton Memorial Hospital Wilmington, Ohio  45177
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland, Oregon  97210
Northwest Cancer Specialists at Rose Quarter Cancer Center Portland, Oregon  97227
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Medical Consultants, Limited Milwaukee, Wisconsin  53215
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - Sheboygan Sheboygan, Wisconsin  53081
Saint Michael's Hospital Cancer Center Stevens Point, Wisconsin  54481
Marshfield Clinic - Wausau Center Wausau, Wisconsin  54401
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Highlands Oncology Group - Fayetteville Fayetteville, Arkansas  72703
Washington Regional Medical Center Fayetteville, Arkansas  72703
Woman's Hospital Baton Rouge, Louisiana  70815
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Bon Secours Cancer Institute at St. Mary's Hospital Richmond, Virginia  23226
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Morton Plant Hospital Clearwater, Florida  33756
Methodist Hospital Houston, Texas  77030
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Three Rivers Community Hospital Grants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical Center Medford, Oregon  97504
Kinston Medical Specialists Kinston, North Carolina  28501
Rocky Mountain Gynecologic Oncology Englewood, Colorado  80110
St. Vincent's Medical Center Jacksonville, Florida  32203
St. Francis Hospital Evanston, Illinois  60202
Freeman Cancer Institute at Freeman Health System Joplin, Missouri  64803-2644
MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
Palm Beach Cancer Institute - West Palm Beach West Palm Beach, Florida  33401
Providence Cancer Center Anchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Center for Cancer Care at OSF Saint Anthony Medical Center Rockford, Illinois  61108
Louisville Oncology at Norton Cancer Institute - Louisville Louisville, Kentucky  40202
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Good Samaritan Hospital Cancer Treatment Center Cincinnati, Ohio  45220
Independence Regional Health Center Independence, Missouri  64050
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
Memorial Medical Center Modesto, California  95355
Mercy General Health Partners Muskegon, Michigan  49443
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center Edgewood, Kentucky  41017
Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center Upland, Pennsylvania  19013
Olive View - UCLA Medical Center Foundation Sylmar, California  91342
Piedmont Hematology-Oncology Associates Winston-Salem, North Carolina  27103
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Providence Cancer Center at PMCC Medford, Oregon  97504
Christus Schumpert Cancer Treatment Center Shreveport, Louisiana  71101
Saint Mary's Regional Medical Center Reno, Nevada  89503
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Mount Sinai Hospital Medical Center Chicago, Illinois  60608
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Alamance Cancer Center at Alamance Regional Medical Center Burlington, North Carolina  27216
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Peninsula Cancer Institute - Newport News Office Newport News, Virginia  23601
Shore Regional Cancer Center at Memorial Hospital - Easton Easton, Maryland  21601
Colorado Gynecologic Oncology Group, PC Aurora, Colorado  80010
Central Georgia Gynecologic Oncology Macon, Georgia  31201
Virginia K. Crosson Cancer Center at St. Jude Medical Center Fullerton, California  92835
Kaiser Permanente Capital Area Medical Group - Shady Grove Facility Rockville, Maryland  20850
Ephrata Cancer Center at Ephrata Community Hospital Ephrata, Pennsylvania  17522
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Clearview Cancer Institute Huntsville, Alabama  35805
California Cancer Care, Incorporated - Greenbrae Greenbrae, California  94904
Florida Gynecologic Oncology - Fort Myers Fort Myers, Florida  33905
Chicago Gynecologic Oncology, SC Palatine, Illinois  60067
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo, Maryland  20774
Kaiser Permanente - Towson Lutherville, Maryland  21093
Gynecologic Oncology of West Michigan Grand Rapids, Michigan  49546
St. Dominic Cancer Center Jackson, Mississippi  39216
Southwest Gynecologic Oncology Associates, Incorporated Albuquerque, New Mexico  87102
Women's Cancer Care Associates Albany, New York  12208
Schwartz Gynecologic Oncology Brightwaters, New York  11718
Black Hills Obstetrics & Gynecology LLP Rapid City, South Dakota  57701
Chattanooga's Program in Women's Oncology Chattanooga, Tennessee  37403
Hall and Martin, M.Ds., PC Knoxville, Tennessee  37920
Northern Virginia Pelvic Surgery Associates Annandale, Virginia  22003
Kaiser Permanente Medical Center - Fair Oaks Fairfax, Virginia  22033
Riverside Middle Peninsula Cancer Center Gloucester, Virginia  23061
Peninsula Cancer Institute - Williamsburg Office Williamsburg, Virginia  23185
Northwest Medical Specialties, PLLC - Tacoma Tacoma, Washington  98405
Vince Lombard Cancer Clinic at Aurora Health Center - Slinger Slinger, Wisconsin  53086
Aurora Women's Pavilion of West Allis Memorial Hospital West Allis, Wisconsin  53227