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

NCT ID: NCT00718523

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.

Group Type: PLACEBO_COMPARATOR

AMG 479 Placebo

Intervention Type: DRUG

Matching placebo administered Day 1 of each 21 day cycle.

B

AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.

Group Type: EXPERIMENTAL

AMG 479

Intervention Type: DRUG

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

Interventions

AMG 479

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

Intervention Type: DRUG

AMG 479 Placebo

Matching placebo administered Day 1 of each 21 day cycle.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Translational Research in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gottfried E Konecny, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

Central Hematology Oncology Medical Group Inc.

Alhambra, California, United States

Providence Saint Joseph Medical Center

Burbank, California, United States

St Jude Heritage Healthcare

Fullerton, California, United States

Wilshire Oncology Medical Group Inc

La Verne, California, United States

University of Southern California

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group

Northridge, California, United States

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

University of California San Francisco

San Francisco, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Memorial Cancer Institute

Hollywood, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute Emory University School of Medicine

Atlanta, Georgia, United States

Hematology and Oncology Specialists, LLC

Metairie, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Hope A Women's Cancer Center

Asheville, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

The Toledo Hospital

Toledo, Ohio, United States

University of Toledo

Toledo, Ohio, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

London Health Science Center

London, Ontario, Canada

CHUM Hopital Notre Dame

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, , France

Centre Léon Bérard

Lyon, , France

Clinique Hartmann

Neuilly-sur-Seine, , France

Institut Curie

Paris, , France

Charite Campus Benjamin Franklin

Berlin, , Germany

University Hospital Charite

Berlin, , Germany

Universitat Bonn

Bonn, , Germany

Universitatsklinikum Erlangen

Erlangen, , Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, , Germany

Universitatsklinikum des Saarlandes

Homburg, , Germany

Klinikum Kassel

Kassel, , Germany

Rotkreuzkrankenhaus Munchen

Munich, , Germany

Universitats Frauenklinik Tubingen

Tübingen, , Germany

St Jame's Hospital

Dublin, , Ireland

Waterford Regional Hospital

Waterford, , Ireland

Meir Medical Center

Kfar Saba, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Asaf Harofe MC

Zrifin, , Israel

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Hospital U 12 de Octubre

Madrid, , Spain

Hospital Universitario de Tenerife

San Cristóbal de La Laguna, , Spain

Hospital Universitario Virgen Macarena de Sevilla

Seville, , Spain

Saint James's University Hospital

Leeds, , United Kingdom

University College London

London, , United Kingdom

Mount Vernon cancer centre

Northwood, , United Kingdom

Countries

United States; Canada; France; Germany; Ireland; Israel; Spain; United Kingdom

Other Identifiers

TRIO 014

Identifier Type: -

Identifier Source: org_study_id