VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Recurrent Endometrial Carcinoma

In brief

This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.

Key facts

Study ID

NCT00462826

Run by

National Cancer Institute (NCI)

People needed

49

Starts

2007-11-01

Expected to finish

2013-01-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed endometrial carcinoma, meeting both of the following criteria:
• 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 collection
• 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

Where it is running

• Lawrence Memorial Hospital — Lawrence, Kansas, United States
• Radiation Oncology Center of Olathe — Olathe, Kansas, United States
• Menorah Medical Center — Overland Park, Kansas, United States
• Radiation Oncology Practice Corporation Southwest — Overland Park, Kansas, United States
• Shawnee Mission Medical Center — Shawnee Mission, Kansas, United States
• Franklin Square Hospital Center — Baltimore, Maryland, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Green Bay Oncology - Escanaba — Escanaba, Michigan, United States
• Green Bay Oncology - Iron Mountain — Iron Mountain, Michigan, United States
• Centerpoint Medical Center LLC — Independence, Missouri, United States
• Truman Medical Center — Kansas City, Missouri, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Radiation Oncology Practice Corporation South — Kansas City, Missouri, United States
• Saint Joseph Health Center — Kansas City, Missouri, United States
• North Kansas City Hospital — Kansas City, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States
• Radiation Oncology Practice Corporation - North — Kansas City, Missouri, United States
• Liberty Hospital — Liberty, Missouri, United States
• Heartland Regional Medical Center — Saint Joseph, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• Southwest Gynecologic Oncology Associates Inc — Albuquerque, New Mexico, United States
• Providence Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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