Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130520
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2005-08-12
Brief Title:
Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Phase II Open-Label Trial of Erlotinib Tarceva and Bevacizumab in Women With Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2010-12
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:
The purpose of this project is to determine if a new combination of drugs erlotinib Tarceva and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane paclitaxel or docetaxel and a platinum cisplatin or carboplatin
Detailed Description:
Erlotinib and bevacizumab novel biologics offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens Because bevacizumab is an anti-angiogenesis drug and erlotinib is an EGFR receptor inhibitor their combination would lead to the inhibition of multiple signal transduction pathways and the reversal of cancer progression in this difficult to treat population The study seeks to determine the efficacy and safety of the EGFR receptor inhibitor erlotinib plus the anti-angiogenesis VEGF ligand inhibitor bevacizumab in women with platinum and taxane refractory ovarian cancer
The study design is a non-randomized open label single center Phase II trial using a Simon two stage design Eligible patients are women who have a histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease
Patients will be treated with erlotinib 150 mgday orally and bevacizumab 10mgkg every two weeks plus or minus one day intravenously Forty patients will be enrolled in the study Initially 20 eligible patients will be accrued If one or no confirmed response is observed the trial will be closed and the agents considered inactive Otherwise 20 additional eligible patients will be accrued for a total of 40 patients Eight or more responses out of 40 will be considered evidence warranting further study of the agents provided other factors such as progression-free and overall survival also appear favorable
Previous studies of this combination in non-small cell lung cancer renal cell carcinoma and metastatic breast cancer have indicated a potential synergistic effect for these two agents Preliminary data for the use of bevacizumab in advanced ovarian cancer indicates that this agent has single-agent activity As a result the researchers are interested in exploring the role of the combination of erlotinib and bevacizumab in advanced ovarian cancer
The study design is a non-randomized open label single center Phase II trial using a Simon two stage design Eligible patients are women who have a histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease
Patients will be treated with erlotinib 150 mgday orally and bevacizumab 10mgkg every two weeks plus or minus one day intravenously Forty patients will be enrolled in the study Initially 20 eligible patients will be accrued If one or no confirmed response is observed the trial will be closed and the agents considered inactive Otherwise 20 additional eligible patients will be accrued for a total of 40 patients Eight or more responses out of 40 will be considered evidence warranting further study of the agents provided other factors such as progression-free and overall survival also appear favorable
Previous studies of this combination in non-small cell lung cancer renal cell carcinoma and metastatic breast cancer have indicated a potential synergistic effect for these two agents Preliminary data for the use of bevacizumab in advanced ovarian cancer indicates that this agent has single-agent activity As a result the researchers are interested in exploring the role of the combination of erlotinib and bevacizumab in advanced ovarian cancer
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