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Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors

NCT01206465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-12-26

Study results available
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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

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jean Grem · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-14
Primary Completion
2015-02-04
Completion
2017-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206465 on ClinicalTrials.gov