Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390000
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2006-10-18
Brief Title:
Vatalanib and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase I Study of PTKZK in Combination With Pemetrexed Disodium ALIMTA
Status:
COMPLETED
Status Verified Date:
2019-04
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:
RATIONALE Vatalanib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Vatalanib may also stop the growth of tumor cells by blocking blood flow to the tumor Giving vatalanib together with pemetrexed disodium may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vatalanib when given together with pemetrexed disodium in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of vatalanib when given together with pemetrexed disodium in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
I To determine the dose limiting toxicity DLT and maximally tolerated dose MTD of PTKZK and pemetrexed disodium when given in combination
II To describe the toxicities associated with the combination of PTKZK with pemetrexed disodium
III To evaluate the pharmacokinetic interaction of combination of PTKZK with pemetrexed disodium at the MTD Group II
IV To evaluate the intracellular content of pemetrexed disodium polyglutamates as a measure of activity of pemetrexed disodium transport and activation enzymes in the MTD expansion cohort Group II
V To evaluate polymorphisms and gene expression of pemetrexed disodium target genes and genes encoding enzymes involved in the transport activation and inactivation of pemetrexed disodium and correlate haplotype-tagged SNPs or gene expression levels with intracellular levels of pemetrexed disodium polyglutamates toxicity andor efficacy or pemetrexed disodium in Group II
VI To evaluate pharmacogenetic metabolic and clinical markers that may predict for hypertension induced by anti-VEGF therapy
OUTLINE
This is a dose-escalation study of vatalanib Patients are assigned to 1 of 2 treatment groups
GROUP I dose escalation closed to accrual 12182007 Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral vatalanib twice daily on days 1-21
GROUP II MTD expansion group Patients receive pemetrexed disodium IV on day 1 as in group I Patients also receive oral vatalanib at the MTD twice daily on days 8-21 during course 1 and on days 1-21 during all subsequent courses
In both groups courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To determine the dose limiting toxicity DLT and maximally tolerated dose MTD of PTKZK and pemetrexed disodium when given in combination
II To describe the toxicities associated with the combination of PTKZK with pemetrexed disodium
III To evaluate the pharmacokinetic interaction of combination of PTKZK with pemetrexed disodium at the MTD Group II
IV To evaluate the intracellular content of pemetrexed disodium polyglutamates as a measure of activity of pemetrexed disodium transport and activation enzymes in the MTD expansion cohort Group II
V To evaluate polymorphisms and gene expression of pemetrexed disodium target genes and genes encoding enzymes involved in the transport activation and inactivation of pemetrexed disodium and correlate haplotype-tagged SNPs or gene expression levels with intracellular levels of pemetrexed disodium polyglutamates toxicity andor efficacy or pemetrexed disodium in Group II
VI To evaluate pharmacogenetic metabolic and clinical markers that may predict for hypertension induced by anti-VEGF therapy
OUTLINE
This is a dose-escalation study of vatalanib Patients are assigned to 1 of 2 treatment groups
GROUP I dose escalation closed to accrual 12182007 Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral vatalanib twice daily on days 1-21
GROUP II MTD expansion group Patients receive pemetrexed disodium IV on day 1 as in group I Patients also receive oral vatalanib at the MTD twice daily on days 8-21 during course 1 and on days 1-21 during all subsequent courses
In both groups 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-2009-01316 | REGISTRY | None | None |
| MC0515 | OTHER | None | None |
| P30CA015083 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP30CA015083 |