RECRUITING

5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab. Arm 1 (Treatment Arm) will consist of the 5FU/LV administered to 38 patients as (LV \[400 mg/m² IV over 120 minutes\], followed by 5FU \[400 mg/m² IV bolus then 2400 mg/m² IV infusion over 46 hours\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on /1 week off until disease progression, up to 12 cycles of treatment. Arm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg/m2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.

Official Title

Randomized Phase II Trial of 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

Quick Facts

Study Start:2025-05-08

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06887218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female ≥18 years of age. 2. Histopathological or cytologically confirmed metastatic CRC. 3. Failed second-line therapy for metastatic disease. 4. A minimum of one measurable disease per RECISTv1.1. 5. ECOG performance status of 0-2. 6. Life expectancy ≥6 months per treating physician or principal investigator. 7. Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. 8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: 9. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator. 10. Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug as outlined in Appendices 12.2 11. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate. 12. Subject must be able to swallow and retain oral medication.	* 1\. Hematology laboratory values of: 1. Absolute neutrophil count ≤1000 cells/mm3 2. Platelets ≤70,000 cells/mm3 3. Hemoglobin ≤9 g/dL 4. White blood count ≤3000 cells/mm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase: 1. \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or 2. \>2.5 × ULN if no liver metastases are present. 3. Serum albumin \<5.8 g/dL. 4. Total bilirubin \>10 mg/dL. 5. Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits. 1. Arrhythmia 2. Bradycardia 3. Tachycardia 4. Symptomatic valvular disease 5. Symptomatic congestive heart failure is classified by New York Heart Association as Class III or IV 6. Unstable angina pectoris. 11. Myocardial infarction within the past 6 months from the consent date. 12. Active bleeding diathesis. 13. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months from the consent date. 1. Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.

Inclusion Criteria

Exclusion Criteria

1. Male or female ≥18 years of age.
2. Histopathological or cytologically confirmed metastatic CRC.
3. Failed second-line therapy for metastatic disease.
4. A minimum of one measurable disease per RECISTv1.1.
5. ECOG performance status of 0-2.
6. Life expectancy ≥6 months per treating physician or principal investigator.
7. Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
9. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
10. Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug as outlined in Appendices 12.2
11. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
12. Subject must be able to swallow and retain oral medication.

* 1\. Hematology laboratory values of:
1. Absolute neutrophil count ≤1000 cells/mm3
2. Platelets ≤70,000 cells/mm3
3. Hemoglobin ≤9 g/dL
4. White blood count ≤3000 cells/mm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
1. \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
2. \>2.5 × ULN if no liver metastases are present. 3. Serum albumin \<5.8 g/dL. 4. Total bilirubin \>10 mg/dL. 5. Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.
1. Arrhythmia
2. Bradycardia
3. Tachycardia
4. Symptomatic valvular disease
5. Symptomatic congestive heart failure is classified by New York Heart Association as Class III or IV
6. Unstable angina pectoris. 11. Myocardial infarction within the past 6 months from the consent date. 12. Active bleeding diathesis. 13. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months from the consent date.
1. Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.

Contacts and Locations

Study Contact

Safiya Joseph

CONTACT

3462382420

sdjoseph@houstonmethodist.org

Titilayo Olubajo

CONTACT

7133639803

tolubajo@houstonmethodist.org

Principal Investigator

Maen Abdelrahim, MD, PhD, Pharm D

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Abdullah Esmail, MD

STUDY_DIRECTOR

Houston Methodist Neal Cancer Center

Study Locations (Sites)

Houston Methodist Neal Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Maen Abdelrahim, MD, PhD, Pharm D, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute
Abdullah Esmail, MD, STUDY_DIRECTOR, Houston Methodist Neal Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08

Study Completion Date2029-12

Study Record Updates

Study Start Date2025-05-08

Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Colorectal Cancer (CRC)