Clinical Trials Directory

Trials / Completed

CompletedNCT00022659

Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
64 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Detailed description

PRIMARY OBJECTIVES: I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug. IV. Determine the frequency of clinical response in patients treated with this drug. V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients. VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALbevacizumabGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2002-04-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2003-01-27
Last updated
2019-07-24
Results posted
2015-05-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00022659. Inclusion in this directory is not an endorsement.