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Anti-metabolites

5-Fluorouracil for Colorectal Cancer

Phase 2

Waitlist Available

Led By Jasmine Huynh, MD

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2

Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU

Must not have

Known dihydropyrimidine dehydrogenase (DPD) deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of treatment at 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if changing the dosage of 5-fluorouracil based on blood concentration can enhance the treatment of metastatic colon cancer.

Who is the study for?

This trial is for individuals with metastatic colorectal cancer. Participants should be suitable for chemotherapy and have not been treated with the study drugs before. Specific details about inclusion and exclusion criteria are not provided, but typically these would relate to overall health status, prior treatments, and other medical conditions.

What is being tested?

The study is testing whether adjusting doses of the chemotherapy drug 5-fluorouracil (5-FU) based on blood concentration levels can improve outcomes in metastatic colon cancer treatment. Other chemo regimens like FOLFIRI, Modified FOLFOX6, and mFOLFOXIRI are also being tested biweekly.

What are the potential side effects?

Common side effects of chemotherapy drugs like 5-FU may include nausea, vomiting, diarrhea, mouth sores, low blood cell counts leading to increased infection risk or bleeding problems. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My colorectal cancer has spread and can be treated with 5-FU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of treatment at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of treatment at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or bothExperimental Treatment4 Interventions

Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.

0 / 3Eligibility criteria met