NCT00390000

Vatalanib and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors

Phase I Study of PTK/ZK in Combination With Pemetrexed Disodium (ALIMTA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. To determine the dose limiting toxicity (DLT) and maximally tolerated dose (MTD) of PTK/ZK and pemetrexed disodium when given in combination. II. To describe the toxicities associated with the combination of PTK/ZK with pemetrexed disodium. III. To evaluate the pharmacokinetic interaction of combination of PTK/ZK 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 and/or 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 12/18/2007): 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	vatalanib	Given orally
DRUG	pemetrexed disodium	Given IV
OTHER	pharmacological study	Correlative study
PROCEDURE	ultrasound imaging	Correlative study

Timeline

• Start date: 2007-01-25
• Primary completion: 2016-08-04
• Completion: 2016-08-04
• First posted: 2006-10-19
• Last updated: 2019-04-08

Locations

1 site across 1 country: United States