Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Gynecologic Cancer

VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer (GOG 0229-F)
A Phase II Evaluation of VEGF-Trap (Aflibercept, NSC# 724770, IND #BB100137, NCI Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status Conditions Phase Study ID
Closed Endometrial Cancer
Gynecological Cancer
Phase II GOG 0229-F
NCT00462826
Summary

RATIONALE: 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.

PURPOSE: This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer.


Investigator
Benjamin Greer, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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
    • 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
Last Updated
March 14, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.