Clinical trial · Interventional
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
A Pilot Study of Pharmacokinetically (PK) Dose Adjusted 5-Fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
NCT06501989CI-TRIAL-00103080withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator has left Inova
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biweekly 5-FLUOROURACIL (5-FU) | Drug | — | UNRESOLVED |
| Biweekly FOLFIRI | Drug | — | UNRESOLVED |
| Biweekly Modified FOLFOX6 | Drug | — | UNRESOLVED |
| mFOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
- description
- 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.
- interventionNames
- Drug: Biweekly 5-FLUOROURACIL (5-FU)
- Drug: Biweekly Modified FOLFOX6
- Drug: Biweekly FOLFIRI
- Drug: mFOLFOXIRI
Primary outcomes (1)
- measure
- Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting
- timeFrame
- From enrollment to the end of treatment at 8 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (15)
- BACKGROUNDTournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2. PMID 14657227
- BACKGROUNDCremolini C, Antoniotti C, Rossini D, Lonardi S, Loupakis F, Pietrantonio F, Bordonaro R, Latiano TP, Tamburini E, Santini D, Passardi A, Marmorino F, Grande R, Aprile G, Zaniboni A, Murgioni S, Granetto C, Buonadonna A, Moretto R, Corallo S, Cordio S, Antonuzzo L, Tomasello G, Masi G, Ronzoni M, Di Donato S, Carlomagno C, Clavarezza M, Ritorto G, Mambrini A, Roselli M, Cupini S, Mammoliti S, Fenocchio E, Corgna E, Zagonel V, Fontanini G, Ugolini C, Boni L, Falcone A; GONO Foundation Investigators. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2020 Apr;21(4):497-507. doi: 10.1016/S1470-2045(19)30862-9. Epub 2020 Mar 9. PMID 32164906
- BACKGROUNDFang L, Xin W, Ding H, Zhang Y, Zhong L, Luo H, Li J, Yang Y, Huang P. Pharmacokinetically guided algorithm of 5-fluorouracil dosing, a reliable strategy of precision chemotherapy for solid tumors: a meta-analysis. Sci Rep. 2016 May 27;6:25913. doi: 10.1038/srep25913. PMID 27229175
- BACKGROUNDMeyerhardt JA, Mayer RJ. Systemic therapy for colorectal cancer. N Engl J Med. 2005 Feb 3;352(5):476-87. doi: 10.1056/NEJMra040958. No abstract available. PMID 15689586
- BACKGROUNDGamelin E, Delva R, Jacob J, Merrouche Y, Raoul JL, Pezet D, Dorval E, Piot G, Morel A, Boisdron-Celle M. Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol. 2008 May 1;26(13):2099-105. doi: 10.1200/JCO.2007.13.3934.