Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

Exclusion Criteria

• •Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
• •Borderline tumors (tumors of low malignant potential).
• •Planned intraperitoneal cytotoxic chemotherapy.
• •Prior systemic anticancer therapy for ovarian cancer.
• •Any previous radiotherapy to the abdomen or pelvis.
• •Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
• •Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
• •Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
• •Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
• •Previous exposure to AMG 479.
• •Anticipation of a need for a major surgical procedure or radiation therapy during the study.
• •History of hypersensitivity to recombinant proteins.
• •Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
• •Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade \> 2 peripheral neuropathy, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
• •History of brain metastases, spinal cord compression, or carcinomatous meningitis.
• •Patient of child-bearing potential is pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
• •Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
• •Known active infection, or on antiretroviral therapy for HIV disease.
• •Known positive test for chronic hepatitis B or C infection.
• •Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
• •Refusal or inability to give informed consent to participate in the study.
• •Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study