Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085553
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2004-06-10
Brief Title:
Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-05
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 I trial studies the side effects and best dose of tipifarnib and erlotinib hydrochloride in treating patients with solid tumors that have spread to other places in the body Tipifarnib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximal tolerated dose of R115777 tipifarnib in combination with OSI-774 erlotinib hydrochloride
II To describe the toxicity profile of this combination III To evaluate the effect of OSI-774 on the disposition of R115777 IV To evaluate in vitro markers of farnesyl transferase FT inhibition and epidermal growth factor receptor EGFR inhibition
OUTLINE This is a dose-escalation study
Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-28 days 8-28 of course 1 as of 1142013 and tipifarnib PO twice daily BID on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Closed to accrual as of 2206
After completion of study treatment patients are followed up at 3 months
I To determine the maximal tolerated dose of R115777 tipifarnib in combination with OSI-774 erlotinib hydrochloride
II To describe the toxicity profile of this combination III To evaluate the effect of OSI-774 on the disposition of R115777 IV To evaluate in vitro markers of farnesyl transferase FT inhibition and epidermal growth factor receptor EGFR inhibition
OUTLINE This is a dose-escalation study
Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-28 days 8-28 of course 1 as of 1142013 and tipifarnib PO twice daily BID on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Closed to accrual as of 2206
After completion of study treatment patients are followed up at 3 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 |
|---|---|---|---|
| NCI-2012-02597 | REGISTRY | None | None |
| NCI-6014 | None | None | None |
| CDR0000370818 | None | None | None |
| MAYO-MC0212 | None | None | None |
| MC0212 | None | None | None |
| MC0212 | OTHER | None | None |
| 6014 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| U01CA069912 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069912 |