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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



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