NCT01206465

Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors

A Phase I Clinical Trial of Sequential Pralatrexate Followed by a 48-hour Infusion of 5- Fluorouracil Given Every Other Week in Adult Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when given together with fluorouracil in treating patients with recurrent solid tumors

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended dose of PDX (pralatrexate) given in combination with a fixed dose of 5-FU (fluorouracil) administered as a 48-hour infusion given every other week. SECONDARY OBJECTIVES: I. To assess clinical response to therapy in subjects with measurable disease and time to disease progression in all subjects. II. To assess the toxicity profile of the combination of PDX and 5-FU. III. To determine the pharmacokinetics of PDX and 5-FU and correlate with clinical toxicity. IV. To analyze polymorphisms in methylenetetrahydrofolate reductase and thymidylate synthase (TS) and correlate with clinical toxicity. OUTLINE: This is a dose-escalation study of pralatrexate. Patients receive pralatrexate intravenously (IV) over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pralatrexate	Given IV
DRUG	fluorouracil	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	DNA analysis	Correlative studies
OTHER	high performance liquid chromatography	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies
GENETIC	nucleic acid sequencing	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	pharmacogenomic studies	Correlative studies
GENETIC	polymorphism analysis	Correlative studies

Timeline

• Start date: 2010-09-14
• Primary completion: 2015-02-04
• Completion: 2017-06-01
• First posted: 2010-09-21
• Last updated: 2023-12-26
• Results posted: 2018-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study