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A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND#61010) and Ixabepilone (NSC#710428, IND#59699) / Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Phase 2
18 Years
Open (Enrolling)
Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Recurrent Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

Thank you

Trial Information

A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND#61010) and Ixabepilone (NSC#710428, IND#59699) / Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer


I. To estimate the hazard of progression or death of each of the three arms relative to that
of historical controls in patients with advanced or recurrent endometrial cancer.


I. To determine the nature, frequency, and maximum degree of toxicity as assessed by CTCAE
v3.0 for each of the three arms.

II. To estimate the distribution of the duration of overall survival for each of the three

III. To estimate the proportion of patients with measurable disease who have confirmed
objective tumor responses by treatment.


I. To explore the associations between select biomarkers and progression-free survival as
well as secondary measures of clinical outcome (overall survival, tumor response, or disease
status if possible) in the context of histologic cell type and treatment.

II. To explore the relationship among the various biomarkers by histologic subtype and

III. To explore which combination of biomarkers and clinical covariates optimally predicts
responsiveness and resistance to the three treatment arms.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and
bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses
in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive bevacizumab beginning
on course 2.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
day 1 and temsirolimus* IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days
for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive temsirolimus IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 21 days in the absence of disease progression or unacceptable

NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive temsirolimus
beginning on course 2.

ARM III: Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and
bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses
in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive bevacizumab beginning
on course 2.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Histologically confirmed endometrial carcinoma, including any of the following
epithelial cell types:

- Endometrioid adenocarcinoma

- Serous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Adenocarcinoma not otherwise specified

- Mucinous adenocarcinoma

- Squamous cell carcinoma

- Transitional cell carcinoma

- Stage III, IVA-B, or recurrent disease

- Refractory to curative or established therapy

- Measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
chest x-ray or ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- No history or evidence of CNS disease, including primary brain tumor, seizures not
controlled with standard medical therapy, or any brain metastases

- Not eligible for a higher priority GOG protocol (any active GOG phase III protocol or
rare tumor protocol), if one exists

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelets ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT and SGPT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Urine protein:creatinine ratio < 1.0 g OR < 1,000 mg by 24-hour urine collection

- INR and PTT ≤ 1.5 times ULN

- Fasting cholesterol < 300 mg/dL

- Fasting triglycerides ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- No other invasive malignancies within the past 3 years, except nonmelanoma skin

- No serious, non-healing wound, ulcer, or bone fracture, including history of
abdominal/pelvic fistula, gastrointestinal perforation, or intraabdominal abscess
within the past 3 months

- No uncorrected underlying lesions that caused the fistula or perforation

- No active bleeding or pathologic conditions that carry high risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels

- No clinically significant cardiovascular disease, including any of the following:

- Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP >
90 mm Hg

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation), or cardiac arrhythmias requiring anti-arrhythmic

- Atrial fibrillation that is well controlled with anti-arrhythmic medication

- Peripheral vascular disease ≥ CTCAE grade 2

- History of cerebrovascular accident (stroke), transient ischemic attack, or
subarachnoid hemorrhage within the past 6 months

- Aortic aneurysm and/or history of aortic dissection

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human or humanized antibodies

- No significant traumatic injury within the past 28 days

- No known history of interstitial pneumonitis

- No hypoxemia ≥ grade 2 by CTCAE v.3

- No dyspnea ≥ grade 2 by CTCAE v.3

- No uncontrolled diabetes or baseline hemoglobin A1C > 8%

- No peripheral neuropathy > grade 1 by CTCAE v.3

- At least 4 weeks since prior radiation therapy (RT) for treatment of endometrial
carcinoma allowed, including pelvic RT, extended field pelvic/para-aortic RT, and/or
intravaginal brachytherapy

- More than 3 years since prior RT to any portion of the abdominal cavity or
pelvis, other than for the treatment of endometrial cancer

- More than 3 years since prior RT for localized cancer of the breast, head and
neck, or skin and no metastatic or recurrent disease

- At least 1 week since prior hormonal therapy for treatment of endometrial carcinoma

- More than 28 days since prior and no concurrent major surgical procedure or open

- More than 7 days since prior minor surgical procedures, fine-needle aspirates, or
core biopsies

- No prior chemotherapy or target therapy (e.g., bevacizumab or other VEGF pathway
targeted therapy, temsirolimus, everolimus, ridaforolimus, sirolimus, or any other
PI3K/AKT/mTor pathway targeted therapy), including chemotherapy used for radiation
sensitization, for treatment of endometrial carcinoma

- More than 3 years since prior chemotherapy for any abdominal or pelvic tumor

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
and no metastatic or recurrent disease

- No prior cancer treatment that contraindicates this protocol therapy

- No concurrent treatment with potent CYP3A4 inhibitors and agents that have CYP3A4
induction potential (arms II and III)

- No concurrent sunitinib malate during temsirolimus treatment (arm II)

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Carol Aghajanian

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Recurrent Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Endometrial Neoplasms
  • Carcinoma, Adenosquamous
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma
  • Adenoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
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Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
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Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Sinai Hospital of Baltimore Baltimore, Maryland  21225
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Avera Cancer Institute Sioux Falls, South Dakota  57105
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Memorial Hospital of South Bend South Bend, Indiana  46601
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University of Texas Medical Branch Galveston, Texas  77555-1329
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William Beaumont Hospital Royal Oak, Michigan  48073
Via Christi Regional Medical Center Wichita, Kansas  67214
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Scott and White Memorial Hospital Temple, Texas  76508
John Muir Medical Center Walnut Creek, California  94598
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Group Health Cooperative Seattle, Washington  98112
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Overlook Hospital Summit, New Jersey  07902-0220
MetroHealth Medical Center Cleveland, Ohio  44109
Central Baptist Hospital Lexington, Kentucky  40503
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Cancer Care Northwest - Spokane South Spokane, Washington  99202
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Elkhart General Hospital Elkhart, Indiana  46515
South Bend Clinic South Bend, Indiana  46617
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Parkland Memorial Hospital Dallas, Texas  75235
Beebe Medical Center Lewes, Delaware  19958
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Geisinger Medical Group State College, Pennsylvania  16801
Miami Valley Hospital Dayton, Ohio  45409
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Seattle Cancer Care Alliance Seattle, Washington  98109
Morton Plant Hospital Clearwater, Florida  33756
Singing River Hospital Pascagoula, Mississippi  39581
Aurora Sinai Medical Center Milwaukee, Wisconsin  53201-0342
Greater Baltimore Medical Center Baltimore, Maryland  21204
Union Hospital of Cecil County Elkton MD, Maryland  21921
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Pacific Gynecology Specialists Seattle, Washington  98104
Washington Hospital Center Washington, District of Columbia  20010
Sherman Hospital Elgin, Illinois  60120-2198
Phelps County Regional Medical Center Rolla, Missouri  65401
Queen's Medical Center Honolulu, Hawaii  96813
University of Virginia Charlottesville, Virginia  22908
New York Hospital Medical Center of Queens Fresh Meadows, New York  11365
Duke University Medical Center Durham, North Carolina  27710
Northwestern University Chicago, Illinois  60611
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Maui Memorial Medical Center Wailuku, Hawaii  96793
Saint Louis University Hospital St. Louis, Missouri  63110-0250
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
University of California at San Diego La Jolla, California  92093
Case Western Reserve University Cleveland, Ohio  44106
Yale University New Haven, Connecticut  06520
Straub Clinic and Hospital Honolulu, Hawaii  96813
Riverside Methodist Hospital Columbus, Ohio  43214
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
University of Texas Southwestern Medical Center Dallas, Texas  
University of Kentucky Lexington, Kentucky  40536-0098
Wichita CCOP Wichita, Kansas  67214-3882
Northwest Hospital Seattle, Washington  98133
Virginia Commonwealth University Richmond, Virginia  
Central Georgia Gynecologic Oncology Macon, Georgia  31201
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
Harrison Medical Center Bremerton, Washington  98310
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
M D Anderson Cancer Center Houston, Texas  77030
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Virginia Oncology Associates - Lake Wright Norfolk, Virginia  23502
University of Cincinnati Cincinnati, Ohio  45267-0502
Hawaii Medical Center East Honolulu, Hawaii  96817
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Froedtert and the Medical College of Wisconsin Milwaukee, Wisconsin  53226
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
University of California San Francisco Medical Center-Mount Zion San Francisco, California  94115
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
The Hospital of Central Connecticut New Britain, Connecticut  06050
M D Anderson Cancer Center- Orlando Orlando, Florida  32806
Oncare Hawaii Inc-POB II Honolulu, Hawaii  96813
Oncare Hawaii Inc-Kuakini Honolulu, Hawaii  96817
University of Hawaii Honolulu, Hawaii  96813
Pacific Cancer Institute of Maui Wailuku, Hawaii  96793
McFarland Clinic Ames, Iowa  50010
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Lakeland Hospital St. Joseph, Michigan  49085
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Cox Medical Center Springfield, Missouri  65807
Cooper Hospital University Medical Center Camden, New Jersey  08103
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
Alamance Regional Medical Center Burlington, North Carolina  27216
Kettering Medical Center Kettering, Ohio  45429
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center-Oncology Clinic Sioux Falls, South Dakota  57104
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Saint Joseph Medical Center Tacoma, Washington  98405
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
Women and Infants Hospital Providence, Rhode Island  02905
Lake University Ireland Cancer Center Mentor, Ohio  44060
Lyndon Baines Johnson General Hospital Houston, Texas  77030
Stony Brook University Medical Center Stony Brook, New York  11794
Elkhart Clinic Elkhart, Indiana  46515
John Muir Medical Center-Concord Campus Concord, California  94520
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
University of Missouri - Ellis Fischel Columbia, Missouri  65203
Renown Regional Medical Center Reno, Nevada  89502
UMDNJ - New Jersey Medical School Newark, New Jersey  07103
Virginia Oncology Associates-Hampton Hampton, Virginia  23666
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin  53081
Hawaii Minority Based CCOP Honolulu, Hawaii  96813
Maine Medical Center-Bramhall Campus Portland, Maine  04102
Center of Hope at Renown Medical Center Reno, Nevada  89502
State University of New York Downstate Medical Center Brooklyn, New York  11203
Hope, A Women's Cancer Center Asheville, North Carolina  28816
Carilion Clinic Gynecological Oncology Roanoke, Virginia  24016
Aurora Women's Pavilion of Aurora West Allis Medical Center West Allis, Wisconsin  53227
Rocky Mountain Gynecologic Oncology PC Englewood, Colorado  80110
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
Saint Dominic-Jackson Memorial Hospital Jackson, Mississippi  39216
Southwest Gynecologic Oncology Associates Inc Albuquerque, New Mexico  87106
Women's Cancer Center of Nevada Las Vegas, Nevada  89109
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii  96766-1099
Providence Regional Cancer Partnership Everett, Washington  98201
Gundersen Lutheran La Crosse, Wisconsin  54601
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California  94040
Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale, Illinois  60521
Saint Vincent Oncology Center Indianapolis, Indiana  46260
University of Massachusetts Memorial Health Care Worcester, Massachusetts  01605
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery Phillipsburg, New Jersey  08865
PeaceHealth Medical Group PC Bellingham, Washington  98226
Skagit Valley Hospital Regional Cancer Care Center Mount Vernon, Washington  98274
Olympic Medical Cancer Care Center Sequim, Washington  98384
Rockwood Cancer Treatment Center Spokane, Washington  99204
Providence Saint Mary Regional Cancer Center Walla Walla, Washington  99362
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin  53215
Methodist West Hospital West Des Moines, Iowa  50266-7700
Jonsson Comprehensive Cancer Center Los Angeles, California  90095
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Summa Akron City Hospital Akron, Ohio  44304
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Veterans Administration-San Diego Medical Center San Diego, California  92161
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
Saint Joseph's Hospital and Medical Center Phoenix, Arizona  85013
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Women's Cancer Care Associates LLC Albany, New York  12208
Island Gynecologic Oncology Brightwaters, New York  11718
Fletcher Allen Health Care-Medical Center Burlington, Vermont  05401
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
South Carolina Oncology Associates PA Columbia, South Carolina  29210
Mercy Cancer Center-West Lakes Clive, Iowa  50325
Mercy Medical Center-West Lakes West Des Moines, Iowa  50266