Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 1:34 PM
Study NCT ID:
NCT00022659
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2001-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: