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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cancer International Research Group
ClinicalTrials.gov Identifier:
NCT00718523
First received: July 17, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: AMG 479
Drug: AMG 479 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Cancer International Research Group:

Primary Outcome Measures:
  • Progression Free Survival (PFS), which is defined as the time from randomization until date of progression or death will be the primary endpoint of this study [ Time Frame: 96 PFS Events - approximately 34 months after the 1st patient is randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time To Progression (TTP) is defined as the interval from the date of randomization to the date of disease progression [ Time Frame: Once 96 PFS events occured - approximately 34 months after the 1st patient is randomized ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
Experimental: 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.
Drug: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718523

Locations
United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
UCLA
Los Angeles, California, United States, 90095-1678
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Central Coast Medical Oncology Corporation
santa Maria, California, United States, 93454
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Winship Cancer Institute Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Louisiana
Hematology and Oncology Specialists, LLC
Marrero, Louisiana, United States, 70072
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
University of Southern California
Rochester, Minnesota, United States, 55905
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28806
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
Cancer International Research Group
Investigators
Study Chair: Gottfried E Konecny, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Cancer International Research Group
ClinicalTrials.gov Identifier: NCT00718523     History of Changes
Other Study ID Numbers: TRIO 014
Study First Received: July 17, 2008
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014