Clinical Trials Directory

Trials / Completed

CompletedNCT01039207

Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase II Evaluation of AMG 102 (Rilotumumab) (NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well rilotumumab works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has failed to respond to other therapies (persistent) or has returned after a period of improvement (recurrent). Rilotumumab is a type of drug called a monoclonal antibody, and may interfere with the ability of tumor cells to grow and spread by targeting certain cells and blocking them from working.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events associated with treatment with AMG 102 (rilotumumab) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). II. To determine the duration of progression-free survival (PFS) and overall survival (OS). TERTIARY OBJECTIVES: I. To explore the association between a panel of biomarkers (as assayed by immunohistochemistry and mutation analysis) and measures of response to treatment with AMG 102 (rilotumumab) and clinical outcome in archived tumor tissue. II. 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 with AMG 102 (rilotumumab) and clinical outcome. OUTLINE: Patients receive rilotumumab intravenously (IV) over 30-60 minutes on days 1 and 14. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALRilotumumabGiven IV

Timeline

Start date
2010-10-01
Primary completion
2012-07-01
Completion
2014-07-01
First posted
2009-12-24
Last updated
2017-09-07
Results posted
2017-09-07

Locations

28 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01039207. Inclusion in this directory is not an endorsement.