Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293345
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2006-02-16
Brief Title:
3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of a Prolonged Infusion of Triapine in Combination With a Fixed Dose Rate of Gemcitabine in Patients With Advanced Solid Tumors and Lymphomas
Status:
COMPLETED
Status Verified Date:
2013-09
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 is studying the best dose of 3-AP and the side effects of giving 3-AP together with gemcitabine in treating patients with advanced solid tumors or lymphoma Drugs used in chemotherapy such as 3-AP and gemcitabine GEM work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing 3-AP may help gemcitabine kill more cancer cells by making the cells more sensitive to the drug 3-AP may also 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 tolerable dose MTD of 3-AP administered as a 24 hour infusion in combination with and fixed-dose gemcitabine hydrochloride GEM in patients with advanced solid tumors or lymphomas
SECONDARY OBJECTIVES
I To define the qualitative and quantitative toxicities of the 3-APGEM combination in regard to organ specificity time course predictability and reversibility
II To document the therapeutic response of this combination in those patients when possible
III To measure deoxycytidine triphosphate dCTP levels in peripheral blood mononuclear cells PBMCs before and after treatment at specified times and try to correlate findings to activity and toxicity of 3-AP
IV To perform limited pharmacokinetic analysis
OUTLINE This is a dose-escalation study of 3-AP TriapinePatients receive 3-AP Triapine IV over 24 hours followed by gemcitabine hydrochloride IV over 100-125 minutes on days 1 and 8 Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Patients achieving complete response CR receive 1 additional course of therapy beyond documented CRCohorts of 3-6 patients receive escalating doses of 3-AP Triapine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicityAfter completion of study treatment patients are followed periodically for 2 years
I To determine the maximal tolerable dose MTD of 3-AP administered as a 24 hour infusion in combination with and fixed-dose gemcitabine hydrochloride GEM in patients with advanced solid tumors or lymphomas
SECONDARY OBJECTIVES
I To define the qualitative and quantitative toxicities of the 3-APGEM combination in regard to organ specificity time course predictability and reversibility
II To document the therapeutic response of this combination in those patients when possible
III To measure deoxycytidine triphosphate dCTP levels in peripheral blood mononuclear cells PBMCs before and after treatment at specified times and try to correlate findings to activity and toxicity of 3-AP
IV To perform limited pharmacokinetic analysis
OUTLINE This is a dose-escalation study of 3-AP TriapinePatients receive 3-AP Triapine IV over 24 hours followed by gemcitabine hydrochloride IV over 100-125 minutes on days 1 and 8 Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Patients achieving complete response CR receive 1 additional course of therapy beyond documented CRCohorts of 3-6 patients receive escalating doses of 3-AP Triapine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicityAfter completion of study treatment patients are followed periodically for 2 years
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 |
|---|---|---|---|
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |
| NCI-2009-00119 | REGISTRY | None | None |
| NCI-7043 | None | None | None |
| OSU-2005C0031 | None | None | None |
| CDR0000455043 | None | None | None |
| OSU 05016 | OTHER | None | None |
| 7043 | OTHER | None | None |