Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors
NCT ID: NCT01206465
Last Updated: 2023-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2010-09-14
2017-06-01
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (enzyme inhibitor therapy)
Patients receive pralatrexate 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.
pralatrexate
Given IV
fluorouracil
Given IV
laboratory biomarker analysis
Correlative studies
DNA analysis
Correlative studies
high performance liquid chromatography
Correlative studies
polymerase chain reaction
Correlative studies
nucleic acid sequencing
Correlative studies
pharmacological study
Correlative studies
pharmacogenomic studies
Correlative studies
polymorphism analysis
Correlative studies
Interventions
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pralatrexate
Given IV
fluorouracil
Given IV
laboratory biomarker analysis
Correlative studies
DNA analysis
Correlative studies
high performance liquid chromatography
Correlative studies
polymerase chain reaction
Correlative studies
nucleic acid sequencing
Correlative studies
pharmacological study
Correlative studies
pharmacogenomic studies
Correlative studies
polymorphism analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Objectively measurable disease is preferred, but not required
* Performance status of 0-2 (Eastern Cooperative Oncology Group \[ECOG\])
* Prior treatment:
* The patient should have recovered from the toxicities associated with prior chemotherapy (at least 3 weeks from prior therapy)
* At least two or more weeks should have elapsed since any radiotherapy, and the patient should have recovered from the toxicity associated with such therapy
* If a recent surgical procedure has been performed, the patient should have recovered from the surgery prior to entering this trial
* Absolute granulocyte count of 1500 per mcL or greater
* Platelet count of 100,000 per mcL or greater
* Serum bilirubin less than 1.5 times the upper limits of the institutional normal
* Serum creatinine less than the upper limits of normal
* The patient must willingly give signed informed consent
Exclusion Criteria
* Serious concurrent medical illness which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety
* Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved
* Patients who are human immunodeficiency virus (HIV) antibody positive and are receiving highly active antiretroviral therapy (HAART) are ineligible
* Concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and trimethoprim/sulfamethoxazole will not be allowed
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Jean Grem
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, United States
Countries
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References
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Grem JL, Kos ME, Evande RE, Meza JL, Schwarz JK. A phase 1 clinical trial of sequential pralatrexate followed by a 48-hour infusion of 5-fluorouracil given every other week in adult patients with solid tumors. Cancer. 2015 Nov 1;121(21):3862-8. doi: 10.1002/cncr.29504. Epub 2015 Aug 4.
Other Identifiers
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NCI-14191
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0238-10-FB
Identifier Type: -
Identifier Source: org_study_id