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Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
This study is not yet open for participant recruitment.
Verified by Cancer International Research Group, July 2008
Sponsored by: Cancer International Research Group
Information provided by: Cancer International Research Group
ClinicalTrials.gov Identifier: NCT00718523
  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 II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Insulin Insulin-like growth factor I Mecasermin rinfabate Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

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: August 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
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.
B: Experimental
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.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718523

Contacts
Contact: Henry Taupin + 33 1 58 10 08 85 henry.taupin@cirg.org

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Cancer International Research Group
Investigators
Study Chair: Gottfried E Konecny, MD University of California, Los Angeles
  More Information

Responsible Party: CIRG ( Mary-Ann LINDSAY, PharmD )
Study ID Numbers: TRIO 014
Study First Received: July 17, 2008
Last Updated: July 17, 2008
ClinicalTrials.gov Identifier: NCT00718523  
Health Authority: United States: Food and Drug Administration;   Germany: Paul-Ehrlich-Institut;   France: Afssaps - French Health Products Safety Agency;   Canada: Health Canada

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Insulin
Antibodies, Monoclonal
Genital Diseases, Female
Antibodies
Endocrinopathy
Immunoglobulins
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 13, 2009