Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096395
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2004-11-09
Brief Title:
Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of BAY 43-9006 in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
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 studying how well giving sorafenib together with gemcitabine works in treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving sorafenib with gemcitabine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES I Objective tumour response rate complete plus partial response as defined by the RECIST criteria in women with recurrent or refractory advanced ovarian or primary peritoneal cancer
SECONDARY OBJECTIVES
I Median survival time II 6-month survival rate III Objective tumour stable disease rate IV Response duration V Toxicity VI Time to disease progression
OUTLINE This is a multicenter study
Course 1 56 days Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43
Course 2 and all subsequent courses 28 days Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients with a complete or partial response receive at least 2 additional courses beyond documented response Patients with stable or responding disease who have received at least 6 courses may discontinue gemcitabine and continue sorafenib alone until disease progression
SECONDARY OBJECTIVES
I Median survival time II 6-month survival rate III Objective tumour stable disease rate IV Response duration V Toxicity VI Time to disease progression
OUTLINE This is a multicenter study
Course 1 56 days Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43
Course 2 and all subsequent courses 28 days Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients with a complete or partial response receive at least 2 additional courses beyond documented response Patients with stable or responding disease who have received at least 6 courses may discontinue gemcitabine and continue sorafenib alone until disease progression
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 |
|---|---|---|---|
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |
| PHL-025 | None | None | None |
| 6565 | None | None | None |