AMG 102 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Recruitment status was Recruiting
RATIONALE: Monoclonal antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well AMG 102 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Malignant Tumor of Peritoneum
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival (PFS) rate at 6 months [ Designated as safety issue: No ]
- Objective tumor response rate [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by the NCI CTCAE [ Designated as safety issue: Yes ]
- Duration of PFS and overall survival (OS) [ Designated as safety issue: No ]
- Association between a panel of biomarkers and measures of response to treatment (including PFS and OS) (translational) [ Designated as safety issue: No ]
- Association between circulating pre- and post-treatment levels of HGF/SF and markers of angiogenesis and measures of response to treatment (including PFS and OS) (translational) [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
- 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.