Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359606
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2006-08-01
Brief Title:
5-Fluoro-2-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase I Trial of 5-Fluoro-2-Deoxycytidine With Tetrahydrouridine
Status:
COMPLETED
Status Verified Date:
2015-05
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 5-fluoro-2-deoxycytidine when given together with tetrahydrouridine in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment advanced Drugs used in chemotherapy such as 5-fluoro-2-deoxycytidine and tetrahydrouridine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of 5-fluoro-2-deoxycytidine 5-fluoro-2-deoxycytidine FdCyd administered by intravenous IV infusion over three hours with concomitant infusion of 350 mgm2 of tetrahydrouridine THU
II To describe the toxicities of FdCyd co-infused with THU
III To obtain preliminary evidence of anti-tumor activity in patients treated with this combination
IV To evaluate the pharmacokinetics of FdCyd and THU when co-infused
V To evaluate the oral bioavailability of FdCyd when co-administered with THU
VI When feasible to measure the relative levels of the messenger ribonucleic acid mRNAs for thymidylate synthase deoxycytidine kinase deoxycytidylate dCMP deaminase and other relevant enzymes and the methylation status of p16 and other genes relevant to neoplasia
OUTLINE This is a dose-escalation study of 5-fluoro-2-deoxycytidine Patients receive tetrahydrouridine orally PO on day 1 5-fluoro-2-deoxycytidine PO on days 1 and 8 tetrahydrouridine IV over 3 hours on days 2-5 8 and 9-12 and 5-fluoro-2-deoxycytidine IV over 3 hours on days 2-5 and 9-12 of course 1 For all subsequent courses patients receive tetrahydrouridine IV over 3 hours and 5-fluoro-2-deoxycytidine IV over 3 hours on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To determine the maximum tolerated dose MTD of 5-fluoro-2-deoxycytidine 5-fluoro-2-deoxycytidine FdCyd administered by intravenous IV infusion over three hours with concomitant infusion of 350 mgm2 of tetrahydrouridine THU
II To describe the toxicities of FdCyd co-infused with THU
III To obtain preliminary evidence of anti-tumor activity in patients treated with this combination
IV To evaluate the pharmacokinetics of FdCyd and THU when co-infused
V To evaluate the oral bioavailability of FdCyd when co-administered with THU
VI When feasible to measure the relative levels of the messenger ribonucleic acid mRNAs for thymidylate synthase deoxycytidine kinase deoxycytidylate dCMP deaminase and other relevant enzymes and the methylation status of p16 and other genes relevant to neoplasia
OUTLINE This is a dose-escalation study of 5-fluoro-2-deoxycytidine Patients receive tetrahydrouridine orally PO on day 1 5-fluoro-2-deoxycytidine PO on days 1 and 8 tetrahydrouridine IV over 3 hours on days 2-5 8 and 9-12 and 5-fluoro-2-deoxycytidine IV over 3 hours on days 2-5 and 9-12 of course 1 For all subsequent courses patients receive tetrahydrouridine IV over 3 hours and 5-fluoro-2-deoxycytidine IV over 3 hours on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| 06-C-0221 | OTHER | National Cancer Institute | None |
| PHI-16 | OTHER | None | None |
| UM1CA62505 | OTHER_GRANT | None | None |
| NCI-2015-00655 | REGISTRY | None | None |