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A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

NCT03750786•Isofol Medical AB

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Colorectal adenocarcinoma verified by biopsy.
•2. Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression.
•3. Non-resectable metastatic CRC planned for first line therapy with 5-FU, Leucovorin, oxaliplatin, and bevacizumab.
•4. Evaluable disease with at least one measurable lesion of metastatic disease (≥10 mm in longest diameter on axial image on CT-scan or alternatively MRI with \<5 mm reconstruction interval) or lymph node (≥ 15 mm in shortest axis when assessed by CT) obtained within 28 days of randomization.
•5. Life expectancy of more than 4 months.
•6. ECOG performance status 0 or 1.
•7. Hemoglobin (Hb) \> 80 g/L, Absolute neutrophil count (ANC) \> 1.5x10E9/L. Thrombocytes \> 100x10E9/L.
•8. Creatinine clearance \> 50 mL/min, Total bilirubin \< 1.5 x ULN, AST and ALT \< 3 x ULN (and \< 5 x ULN in case of liver metastases).
•9. Male or female ≥18 years of age.
•10. Female patients of childbearing potential must have a negative urine pregnancy test and use adequate contraceptive measures . Male patients must use adequate contraceptive measures .
+1 more criteria

Exclusion Criteria

•1. Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
•2. Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.)
•3. Confirmation of progressive disease within 6 months after completion of prior adjuvant anti-cancer treatment.
•4. Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment.
•5. Prior treatment with arfolitixorin.
•6. Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC.
•7. Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency.
•8. Known or suspected central nervous system (CNS) metastases.
•9. Unresolved bowel obstruction, uncontrolled Crohn's disease, or ulcerative colitis.
•10. History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment.
+10 more criteria

Locations (94)

840-24 - Banner Gateway Medical Center

Gilbert, Arizona, United States

840-15 - University of Southern California

Los Angeles, California, United States

840-01 - HOAG Memorial Hospital

Newport Beach, California, United States

840-13 - UCH-MHS d/b/a Memorial Health System

Colorado Springs, Colorado, United States

840-34 - Banner MD Anderson Cancer Center

Greeley, Colorado, United States

840-32 - University of Miami

Miami, Florida, United States

840-08 - Pinellas Hematology Oncology

St. Petersburg, Florida, United States

840-30 - Joliet Oncology-Hematology Associates

Joliet, Illinois, United States

840-06 - Cancer Center of Kansas

Wichita, Kansas, United States

840-29 - Ashland-Bellefonte Cancer Center

Ashland, Kentucky, United States

Key Dates

Start Date

December 18, 2018

Primary Completion Date

November 18, 2022

Completion Date

November 18, 2022

Last Updated

October 26, 2023

Enrollment

490

ACTUAL participants

Conditions

Colo-rectal Cancer

Interventions

Arfolitixorin

DRUG

Leucovorin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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