Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer
Condition: Endometrial Carcinoma
MeSH terms: Endometrial Neoplasms
Intervention: carboplatin, paclitaxel, and bevacizumab
Intervention description: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.