Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025233
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2001-10-11
Brief Title:
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bevacizumab rhuMAB VEGF NSC 704865 in the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix Group A
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 cancer of the cervix 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:
OBJECTIVES
I Determine the cytostatic antitumor activity of bevacizumab in terms of 6-month progression-free survival PFS in patients with persistent or recurrent squamous cell carcinoma of the cervix
II Determine the nature and degree of toxicity of this drug in these patients III Estimate the distribution of PFS and overall survival for patients treated with this drug
IV Determine the frequency of clinical response partial and complete in patients treated with this drug
V Determine the role of age and initial performance status as prognostic factors in patients treated with this drug
VI Determine whether biological and imaging markers are associated with clinical efficacy of this drug such as 6-month PFS in these patients
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 3 weeks 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
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 11-38 months
I Determine the cytostatic antitumor activity of bevacizumab in terms of 6-month progression-free survival PFS in patients with persistent or recurrent squamous cell carcinoma of the cervix
II Determine the nature and degree of toxicity of this drug in these patients III Estimate the distribution of PFS and overall survival for patients treated with this drug
IV Determine the frequency of clinical response partial and complete in patients treated with this drug
V Determine the role of age and initial performance status as prognostic factors in patients treated with this drug
VI Determine whether biological and imaging markers are associated with clinical efficacy of this drug such as 6-month PFS in these patients
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 3 weeks 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
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 11-38 months
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-2012-02416 | REGISTRY | None | None |
| CDR0000068940 | None | None | None |
| GOG-0227C | OTHER | None | None |
| GOG-0227C | OTHER | None | None |