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A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Endometrial Carcinoma

Thank you

Trial Information

A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial
cancer, in terms of the frequency of patients who have progression-free survival for at
least 6 months after initiating therapy or have objective tumor response.

II. Determine the toxicity of this drug in these patients.


I. Determine the duration of progression-free survival and overall survival of patients
treated with this drug.


Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.

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

Inclusion Criteria:

- Histologically confirmed endometrial carcinoma, meeting both of the following

- Recurrent or persistent disease

- Refractory to curative therapy or established treatments

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- Tumors within a previously irradiated field are designated as nontarget lesions
unless progression is documented or a biopsy is obtained to confirm persistence
at least 90 days after completion of radiotherapy

- Must have received one prior chemotherapeutic regimen for management of endometrial
carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or
extended therapy administered after surgical or non-surgical assessment)

- Not a candidate for a higher priority GOG protocol

- No history or evidence of primary brain tumor or brain metastases

- GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1
(patients who received 2 prior regimens)

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Urine protein:creatinine ratio < 1.0 OR urine protein < 1.0 g by 24-hour urine

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

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PT/PTT/INR ≤ 1.5 times ULN

- In-range INR (between 2 and 3) allowed if patient is on a stable dose of
therapeutic warfarin

- QTc < 500 msec

- No evidence of serious ventricular arrhythmia

- Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row

- LVEF normal

- Ejection fraction ≥ 50% (for patients who received prior anthracycline,
including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)

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

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 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

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 2

- Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or
subarachnoid hemorrhage within the past 6 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study therapy

- No HIV positivity

- No neuropathy (sensory and motor) > grade 1

- No active infection requiring antibiotics

- No other invasive malignancies or any evidence of other cancer within the past 5
years except for nonmelanoma skin cancer

- No serious nonhealing wound, ulcer, or bone fracture

- No history of abdominal fistula or gastrointestinal perforation

- No history or evidence of seizures not controlled with standard medical therapy

- No intra-abdominal abscess within the past 28 days

- No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g.,
bleeding disorder, coagulopathy, or tumor involving major vessels)

- 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 concurrent combination antiretroviral therapy for HIV-positive patients

- Recovered from prior surgery

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
or radiotherapy and recovered

- At least 1 week since prior hormonal therapy

- Concurrent hormone replacement therapy allowed

- At least 3 weeks since any other prior therapy, including immunologic agents

- One additional prior cytotoxic regimen for management of recurrent or persistent
endometrial cancer allowed

- Cytotoxic regimens include any agent that targets the genetic and/or mitotic
apparatus of dividing cells, resulting in dose-limiting toxicity to the bone
marrow and/or gastrointestinal mucosa

- More than 28 days since prior major surgery or open biopsy

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

- No prior cancer treatment that would preclude study compliance

- No prior noncytotoxic chemotherapy for management of recurrent or persistent
endometrial disease

- No prior VEGF Trap or other VEGF pathway-targeted therapy

- More than 5 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis except for the treatment of endometrial cancer

- More than 3 years since prior radiotherapy for localized cancer of the breast,
head and neck, or skin

- Patient must remain free of recurrent or metastatic disease

- More than 5 years since prior chemotherapy for any abdominal or pelvic tumor except
for the treatment of endometrial cancer

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer

- Patient must remain free of recurrent or metastatic disease

- Concurrent low-molecular weight heparin allowed for the prevention or treatment of
venous thromboembolic disease if condition is considered clinically stable with

- No other concurrent investigational agents

- No concurrent major surgery

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Robert Coleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • Recurrent Endometrial Carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms



Johns Hopkins University Baltimore, Maryland  21205
Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Washington University School of Medicine Saint Louis, Missouri  63110
Abington Memorial Hospital Abington, Pennsylvania  19001
University of Washington Medical Center Seattle, Washington  98195-6043
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Gynecologic Oncology Network Greenville, North Carolina  27858
Hartford Hospital Hartford, Connecticut  06102-5037
Franklin Square Hospital Center Baltimore, Maryland  21237
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
MetroHealth Medical Center Cleveland, Ohio  44109
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Miami Valley Hospital Dayton, Ohio  45409
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Washington Hospital Center Washington, District of Columbia  20010
Fairview Hospital Cleveland, Ohio  44111
Providence Medical Center Kansas City, Kansas  66112
Independence Regional Health Center Independence, Missouri  64050
Northwestern University Chicago, Illinois  60611
Case Western Reserve University Cleveland, Ohio  44106
Riverside Methodist Hospital Columbus, Ohio  43214
University of New Mexico Albuquerque, New Mexico  87131
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
M D Anderson Cancer Center Houston, Texas  77030
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
The Hospital of Central Connecticut New Britain, Connecticut  06050
Saint Vincent Hospital and Health Services Indianapolis, Indiana  46260
Radiation Oncology Practice Corporation Southwest Overland Park, Kansas  66210
Green Bay Oncology - Escanaba Escanaba, Michigan  49431
Green Bay Oncology - Iron Mountain Iron Mountain, Michigan  49801
Radiation Oncology Practice Corporation - North Kansas City, Missouri  64154
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Radiation Oncology Practice Corporation South Kansas City, Missouri  64114
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Cooper Hospital University Medical Center Camden, New Jersey  08103
Mount Carmel Health Center West Columbus, Ohio  43222
Saint Vincent Hospital Green Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay, Wisconsin  54303
Saint Mary's Hospital Green Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin  54301-3526
Green Bay Oncology - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
Cancer Care Associates-Midtown Tulsa, Oklahoma  74104
Women and Infants Hospital Providence, Rhode Island  02905
Lake University Ireland Cancer Center Mentor, Ohio  44060
Jupiter Medical Center Jupiter, Florida  33458
University of Illinois Chicago, Illinois  60612
Stony Brook University Medical Center Stony Brook, New York  11794
Carilion Clinic Gynecological Oncology Roanoke, Virginia  24016
Northwest Medical Specialties PLLC Tacoma, Washington  98405
Southwest Gynecologic Oncology Associates Inc Albuquerque, New Mexico  87106
Radiation Oncology Center of Olathe Olathe, Kansas  66061