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


About this study

The purpose of this study is to determine the value of adding AMG 479 (a fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin (first line chemotherapy) for the treatment of patients who have ovarian epithelial cancer that has been surgically removed to less than 1 cm thick.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma
  • Has undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction
    • Must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting
  • Stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease
  • Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline
  • No prior systemic treatment in the primary disease treatment setting
  • Female > 18 years of age or legal age
  • ECOG performance status ≤ 2
  • Adequate organ and bone marrow function
  • Non diabetic patients or Type 1 or 2 Diabetic Patients
  • Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL
  • Must be willing and able to comply with scheduled visits, and all study procedures
  • Informed consent obtained
  • Should be able to commence systemic therapy within 6 weeks of cytoreductive surgery
  • Life expectancy > 12 weeks
  • Adequate coagulation parameters within 14 days prior to randomization
    • International Normalized Ratio (INR) ≤1.5
    • Activated Prothrombin Time (APTT) ≤ 1.5 x ULN

Exclusion Criteria

  • Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors
  • Borderline tumors (of low malignant potential)
  • Planned intraperitoneal cytotoxic chemotherapy
  • Prior systemic anticancer therapy for ovarian cancer
  • Any previous radiotherapy to the abdomen or pelvis
  • 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
    • Other thromboembolic event
  • History of brain metastases, spinal cord compression, or carcinomatous meningitis
  • Of child-bearing potential and pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding
  • Of child-bearing potential and 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Haluska, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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