Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100750
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2005-01-06
Brief Title:
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-10
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 III trial is studying the side effects and best dose of tipifarnib when given together with gemcitabine hydrochloride and to see how well they work in treating women with breast cancer that has spread to other parts of the body Tipifarnib is a drug that binds to specific proteins on the tumor cells and then kills these cells Gemcitabine hydrochloride is a chemotherapy drug that may kill tumor cells by preventing cells from dividing Giving tipifarnib together with gemcitabine hydrochloride may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the objective response rate of the combination of gemcitabine gemcitabine hydrochloride and the farnesyltransferase inhibitor tipifarnib R115777 in patients with metastatic breast cancer
II To evaluate the duration of response time to disease progression in patients with metastatic breast cancer treated with the combination of gemcitabine and tipifarnib R115777
OUTLINE This is a phase I dose-escalation study of tipifarnib followed by a phase II study
Patients receive tipifarnib orally PO twice daily BID on days 1-14 and gemcitabine hydrochloride intravenously IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To evaluate the objective response rate of the combination of gemcitabine gemcitabine hydrochloride and the farnesyltransferase inhibitor tipifarnib R115777 in patients with metastatic breast cancer
II To evaluate the duration of response time to disease progression in patients with metastatic breast cancer treated with the combination of gemcitabine and tipifarnib R115777
OUTLINE This is a phase I dose-escalation study of tipifarnib followed by a phase II study
Patients receive tipifarnib orally PO twice daily BID on days 1-14 and gemcitabine hydrochloride intravenously IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| NCI-2009-00114 | REGISTRY | None | None |
| CDR0000409695 | None | None | None |
| 2003-0992 | OTHER | None | None |
| 7004 | OTHER | None | None |
| P30CA016672 | NIH | None | None |
| N01CM17003 | NIH | None | None |
| N01CM62202 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62202 |