Gynecologic Cancer
| Status | Conditions | Phase | Study ID |
| Closed | Endometrial Cancer Gynecological Cancer |
Phase II |
GOG 0229-F NCT00462826 |
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed endometrial carcinoma, meeting both of the following criteria:
- Recurrent or persistent disease
- Refractory to curative therapy or established treatments
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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
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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
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No evidence of serious ventricular arrhythmia
- Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row
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LVEF normal
- Ejection fraction ≥ 50% (for patients who received prior anthracycline, including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)
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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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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.
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