Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out whether the addition of a drug called Avastin (avastin) to the two-drug combination of carboplatin and paclitaxel shrinks tumors better than the two-drug combination alone in the treatment of endometrial cancer. Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that feed the tumor cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Endothelial Growth Factors; Mitogens; Paclitaxel

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed primary Stage III or Stage IV (see FIGO staging-Appendix I) or recurrent endometrial carcinoma with MEASURABLE disease whose potential for cure by radiation therapy or surgery alone or in combination is very poor. Recurrent disease must be biopsy confirmed.

• Patients may have received prior cytotoxic chemotherapy

(1 therapy) excluding a platinum/taxane. Patients may have received prior hormonal therapy or therapy with biologic agents, but such therapies must be discontinued 4 weeks prior to entry on this study.

• Patients in whom both radiation and chemotherapy is planned may receive radiation prior to entry on this study (order not specified). At least four weeks should have elapsed since completion of RT involving the whole pelvis or over 50% of the spine.

• Patients must be 18 years of age or older.

Exclusion Criteria:

• Patients with a concomitant malignancy other than Genentech, Inc Page 27 of 62 Bevacizumab Protocol 03-10-08 Page 27 non-melanoma skin cancer. Patients with a prior malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy.

• Patients in whom pathological confirmation of the tumor is not obtainable.

• 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.

• Life expectancy of less than 12 weeks.

• Patients who are sensitive to E. Coli-derived drug preparations.

• 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.