Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436215
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2007-02-15
Brief Title:
Sorafenib and Bevacizumab to Treat Ovarian Fallopian and Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Sorafenib and Bevacizumab in Epithelial Ovarian Fallopian and Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Background
Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels that allow tumors to grow Using the two drugs together may more effectively block the formation of blood vessels that feed tumors
Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use in other cancers but have not ovarian cancer In a preliminary trial of this drug combination however tumors in 6 of 14 patients with ovarian cancer shrank
Objectives
To determine the safety and activity of the combination of sorafenib and bevacizumab for treating patients with ovarian fallopian and peritoneal cancer
To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of different proteins in small biopsy samples of tumor taken before starting treatment and after 6 weeks
Eligibility
Females 18 years of age and older with ovarian fallopian or peritoneal cancer whose disease has not responded to standard treatment or for which no standard treatment is available
Patients must have not been previously treated with bevacizumab or must have had their disease worsen while taking bevacizumab-based therapy
Design
Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week and 5 mgkg of bevacizumab through a vein every 2 weeks
Tumor biopsies and imaging scans magnetic resonance imaging MRI and positron emission tomography PET are done before treatment 3 days after beginning treatment and 6 weeks into therapy
Computed tomography CT or other imaging tests are done every 8 weeks to evaluate response to treatment
History physical examinations blood and urine tests are done periodically during treatment for health checks and research purposes
About 74 patients are to be enrolled in the trial
Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels that allow tumors to grow Using the two drugs together may more effectively block the formation of blood vessels that feed tumors
Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use in other cancers but have not ovarian cancer In a preliminary trial of this drug combination however tumors in 6 of 14 patients with ovarian cancer shrank
Objectives
To determine the safety and activity of the combination of sorafenib and bevacizumab for treating patients with ovarian fallopian and peritoneal cancer
To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of different proteins in small biopsy samples of tumor taken before starting treatment and after 6 weeks
Eligibility
Females 18 years of age and older with ovarian fallopian or peritoneal cancer whose disease has not responded to standard treatment or for which no standard treatment is available
Patients must have not been previously treated with bevacizumab or must have had their disease worsen while taking bevacizumab-based therapy
Design
Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week and 5 mgkg of bevacizumab through a vein every 2 weeks
Tumor biopsies and imaging scans magnetic resonance imaging MRI and positron emission tomography PET are done before treatment 3 days after beginning treatment and 6 weeks into therapy
Computed tomography CT or other imaging tests are done every 8 weeks to evaluate response to treatment
History physical examinations blood and urine tests are done periodically during treatment for health checks and research purposes
About 74 patients are to be enrolled in the trial
Detailed Description:
Background
Sorafenib is an inhibitor of wild-type and mutant proto-oncogene BRaf B-Raf and proto-oncogene c-Raf c-Raf kinase isoforms in vitro but it also inhibits mitogen-activated protein kinase p38 proto-oncogene c-kit c-kit vascular endothelial growth factor receptor 2 VEGFR-2 and platelet-derived growth factor PDGFR-Beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf
Bevacizumab is a humanized immunoglobulin G 1 IgG1 monoclonal antibody MAb that binds all biologically active isoforms of human vascular endothelial growth factor vascular endothelial growth factor VEGF or VEGF-A with high affinity kd 11nM
Phase I trial of sorafenib and bevacizumab administered concurrently showed activity of the combination in patients with refractory ovarian cancer
Objectives
Determine the activity and tolerability of the combination bevacizumab and sorafenib in patients with refractory or recurrent epithelial ovarian fallopian or peritoneal cancer in patients who are bevacizumab-naive or bevacizumab-resistant
Eligibility
Adults with histologically documented refractory or recurrent epithelial ovarian fallopian or peritoneal cancer
Patients must be off prior chemotherapy radiation therapy hormonal therapy or biological therapy for at least 4 weeks
Patients must have an Eastern Cooperative Oncology Group ECOG of 1 or less
Patients must have disease that is amenable to biopsy
Patients must have not been previously treated with bevacizumab or must have progressed on prior bevacizumab-based therapy
Design
Patients will be stratified on entrance to the trial based on their previous exposure to bevacizumab to either strata A bevacizumab-naive patients or strata B patients previously treated with bevacizumab
Patients will receive oral sorafenib 200 mg twice daily 5 out of 7 days each week and intravenous bevacizumab 5 mgkg every two weeks
Tumor biopsies will be obtained from patients before treatment and six weeks into therapy Dynamic contrast-enhanced magnetic resonance imaging DCE-MRI and fludeoxyglucose 18F-positron emission tomography FDG-PET will be obtained from patients before treatment on day 3 of treatment and six weeks into therapy
Patients will be evaluated for response every 8 weeks using the Response Evaluation Criteria in Solid Tumors RECIST criteria
Approximately 74 patients will be needed to achieve the objectives of the trial
Sorafenib is an inhibitor of wild-type and mutant proto-oncogene BRaf B-Raf and proto-oncogene c-Raf c-Raf kinase isoforms in vitro but it also inhibits mitogen-activated protein kinase p38 proto-oncogene c-kit c-kit vascular endothelial growth factor receptor 2 VEGFR-2 and platelet-derived growth factor PDGFR-Beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf
Bevacizumab is a humanized immunoglobulin G 1 IgG1 monoclonal antibody MAb that binds all biologically active isoforms of human vascular endothelial growth factor vascular endothelial growth factor VEGF or VEGF-A with high affinity kd 11nM
Phase I trial of sorafenib and bevacizumab administered concurrently showed activity of the combination in patients with refractory ovarian cancer
Objectives
Determine the activity and tolerability of the combination bevacizumab and sorafenib in patients with refractory or recurrent epithelial ovarian fallopian or peritoneal cancer in patients who are bevacizumab-naive or bevacizumab-resistant
Eligibility
Adults with histologically documented refractory or recurrent epithelial ovarian fallopian or peritoneal cancer
Patients must be off prior chemotherapy radiation therapy hormonal therapy or biological therapy for at least 4 weeks
Patients must have an Eastern Cooperative Oncology Group ECOG of 1 or less
Patients must have disease that is amenable to biopsy
Patients must have not been previously treated with bevacizumab or must have progressed on prior bevacizumab-based therapy
Design
Patients will be stratified on entrance to the trial based on their previous exposure to bevacizumab to either strata A bevacizumab-naive patients or strata B patients previously treated with bevacizumab
Patients will receive oral sorafenib 200 mg twice daily 5 out of 7 days each week and intravenous bevacizumab 5 mgkg every two weeks
Tumor biopsies will be obtained from patients before treatment and six weeks into therapy Dynamic contrast-enhanced magnetic resonance imaging DCE-MRI and fludeoxyglucose 18F-positron emission tomography FDG-PET will be obtained from patients before treatment on day 3 of treatment and six weeks into therapy
Patients will be evaluated for response every 8 weeks using the Response Evaluation Criteria in Solid Tumors RECIST criteria
Approximately 74 patients will be needed to achieve the objectives of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 07-C-0058 | None | None | None |