Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022659
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2001-08-10
Brief Title:
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02400 | REGISTRY | None | None |
| CDR0000068839 | None | None | None |
| GOG-0170D | OTHER | None | None |
| GOG-0170D | OTHER | None | None |