Overview

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

Status:
Terminated
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
Female
Summary
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Translational Research in Oncology
Treatments:
Antibodies, Monoclonal
Criteria
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.

- Patients should have undergone surgical debulking, by a surgeon experienced in the
management of ovarian cancer, with the aim of maximal surgical cytoreduction. All
patients must be optimally debulked as defined as having no residual tumor of greater
than 1 cm in the post surgical setting.

- Patients with 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.

- Patient must be willing and able to comply with scheduled visits, and all study
procedures.

- Informed consent obtained.

- Patients 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 (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