A Phase II Evaluation of AMG 102 (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
OBJECTIVES:
Primary
- To estimate the 6-month progression-free survival (PFS) rate in patients with
persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma treated with fully human anti-HGF monoclonal antibody AMG 102.
- To estimate the objective tumor response (complete or partial response) rate in
patients treated with this drug.
Secondary
- To determine the frequency and severity of adverse events associated with this drug in
these patients.
- To determine the duration of PFS and overall survival of patients treated with this
drug.
Tertiary
- To explore the association between a panel of biomarkers (as assayed by IHC and
mutation analysis) and measures of response to treatment and clinical outcome in
archived tumor tissue. (Translational)
- To evaluate circulating pre- and post-treatment levels of hepatocyte growth
factor/scatter factor and markers of angiogenesis, and their association with response
to treatment and clinical outcome. (Translational)
OUTLINE: This is a multicenter study.
Patients receive fully human anti-HGF monoclonal antibody AMG 102 IV over 30-60 minutes on
day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable
toxicity.
Tumor tissue and blood samples may be collected periodically for further laboratory
analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate at 6 months
No
Lainie Martin, MD
Principal Investigator
Fox Chase Cancer Center
Unspecified
CDR0000662115
NCT01039207
December 2009
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Gynecologic Oncology | Hinsdale, Illinois 60521 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
All Saints Episcopal Hospital - Fort Worth | Fort Worth, Texas 76104 |