Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

NCT06501989 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: INOVA-2024-27
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

5-fluorouracil (5-FU); pharmacokinetic assay

Outcome Measures

Primary Outcomes (1)

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

  The Feasibility Of Pharmacokinetically Guided Does Adjustment of 5-Fluorouracil In a Community Oncology Setting is Defined as 80% Success Rate among Patients Who Has Completed Four Sequential PK blood Draws with Subsequent Dose Adjustments During the Treatment with 5-FU based Drug Therapy.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

EXPERIMENTAL

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.

Drug: Biweekly 5-FLUOROURACIL (5-FU); Drug: Biweekly Modified FOLFOX6; Drug: Biweekly FOLFIRI; Drug: mFOLFOXIRI

Interventions

Biweekly 5-FLUOROURACIL (5-FU) DRUG

5-FU 2400 mg/m². Infusion for 46 hours. Leucovorin 200 mg/m². Either a vascular endothelial growth factor (VEGF) inhibitor or epidermal growth factor (EGFR) inhibitor or may be added to the regimen at the discretion of the treating physician. Repeat every 2 weeks.

Also known as: 5-FU

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

Biweekly Modified FOLFOX6 DRUG

Oxaliplatin 85 mg/m². 5-FU 400 mg/m² on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m² Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks

Also known as: fluorouracil, leucovorin, oxaliplatin combined

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

Biweekly FOLFIRI DRUG

Irinotecan 180 mg/m2. 5-FU 400 mg/m2 on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m2 Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks.

Also known as: irinotecan with fluorouracil (5FU) and folinic acid combined

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

mFOLFOXIRI DRUG

Irinotecan 165 mg/m2. Oxaliplatin 85 mg/m2. 5-FU 2400 mg/m2 Infusion for 46 hours. Repeat every 2 weeks.

Also known as: folinic acid, fluorouracil (5FU), oxaliplatin, irinotecan combined

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females at least 18 years of age.
• Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU.
• No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease.
• Adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2.
• Life expectancy \> 3 months.

You may not qualify if:

• Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids.
• At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Health Care Service

Falls Church, Virginia, 22042, United States

Location

Related Publications (15)

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Jasmine Huynh, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each cycle of chemotherapy is 2 weeks long, so you will be receiving treatment on the study for a total of 8 weeks. You will also need additional imaging (CT scans) after you complete the first four cycles of chemotherapy, which brings your total time in the study to about 3 months including treatment and follow-up.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: September 19, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)