A Phase II Trial of a Vascular Endothelial Growth Factor (VEGF) Monoclonal Antibody, AVASTIN, in Combination With Cytotoxic Chemotherapy CARBOPLATIN and PACLITAXEL for Recurrent/Advanced Endometrial Cancer
- Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients
with a prior malignancy who have been disease-free for greater than 5 years or who
received prior chemotherapy for that malignancy.
- Patients in whom pathological confirmation of the tumor is not obtainable. General
- Patients with concomitant medical illness such as serious uncontrolled infection,
uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the
treating physician, make the treatments prescribed on this study unreasonably hazardous
for the patient.
- Patients with third degree or complete heart block are not eligible unless a pacemaker
is in place. Patients on medications which alter cardiac conduction, such as digitalis,
beta-blockers, or calcium channel blockers, or who have other conduction abnormalities
or cardiac dysfunction may be placed on study at the discretion of the investigator.
- Patients whose circumstances will not permit study completion or adequate follow-up.
- Patients who are sensitive to E. Coli-derived drug preparations.
- Life expectancy of less than 12 weeks.
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a Genentech-sponsored avastin
- Inadequately controlled hypertension (defined as systolic blood pressure greater than
150 and/or diastolic blood pressure greater than 100 mmHg on antihypertensive
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
- History of myocardial infarction or unstable angina within 6 months prior to study
- History of stroke or transient ischemic attack within 6 months prior to study
- Known CNS disease.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection). Symptomatic
peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy. Blood coagulation parameters: PT such
that international normalized ratio (INR) is less than 1.5 (or an in range INR, between
2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT less than
1.5 times the institutional upper limit of normal.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study.
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access
device, within 7 days prior to study enrollment.
-History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess
within 6 months prior to study enrollment. Patients with clinical symptoms or signs of
gastrointestinal obstruction and who require parenteral hydration and/or nutrition.
- Serious, non-healing wound, ulcer, or bone fracture.
- Proteinuria at screening as demonstrated by:
- Urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening
- Known hypersensitivity to any component of avastin.
- Pregnant (positive pregnancy test) or lactating. Refusal to use of effective means of
contraception (men and women) in subjects of child-bearing potential.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the progression free survival (PFS=date of progression of disease or death) at 6 months using bevacizumab, carboplatin, and paclitaxel in patients with measurable disease for advanced/recurrent endometrial cancer
Peter Rose, MD
The Cleveland Clinic
United States: Food and Drug Administration
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