Status:
COMPLETED
Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Endometrial Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 combi...
Detailed Description
Exclusion Criteria Disease-Specific Exclusions * Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients with a prior malignancy who have been disease-free for greater t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00879359
Start Date
December 1 2007
End Date
February 1 2012
Last Update
April 26 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44129