Clinical Trials Directory

Trials / Completed

CompletedNCT04761614

Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

A Phase I Study of Riluzole in Combination With mFOLFOX6/Bevacizumab in Patients With Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Ning Jin · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is to find out the best dose, possible benefits, and/or side effects of riluzole and how well it works in combination with standard of care mFOLFOX6 and bevacizumab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Riluzole is a well-tolerated oral medication that has demonstrated it may make chemotherapy work better. Chemotherapy drugs, such as oxaliplatin, leucovorin calcium and fluorouracil, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is an antibody that targets the blood vessel by blocking the activity of a protein called vascular endothelial growth factor alpha (VEGF-A). It helps to make the mFOLFOX6 more effective. Giving riluzole, mFOLFOX6, and bevacizumab may kill more tumor cells compared to mFOLFOX6 and bevacizumab alone in treating patients with colorectal cancer.

Detailed description

PRIMARY OBJECTIVE: I. Characterize the safety and toxicity of riluzole in combination with modified (m) leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) 6/bevacizumab and determine the recommended phase II dose (RP2D) of riluzole in combination with mFOLFOX6/bevacizumab in patients with metastatic colorectal cancer. SECONDARY OBJECTIVE: I. Determine the pharmacokinetics of riluzole in patients with metastatic CRC. EXPLORATORY OBJECTIVES: I. Assess the efficacy of the combination treatment. II. Determine the effect of riluzole in downstream GRM3 signaling by immunofluorescent staining of phosphorylated (p)AKT and pCREB in pre- and post-treatment tumor tissues. III. Assess FCGRT/FcRn expression, bevacizumab pharmacokinetics, inflammatory cytokines, and cachexia associated factors as early biomarkers for resistance to therapy. IV. Assess cytotoxic T cells in peripheral blood to evaluate the immunomodulatory effect of this therapy. OUTLINE: This is a dose-escalation study of riluzole. Patients receive riluzole orally (PO) twice daily (BID) on days 1-14. Patients also receive oxaliplatin via intravenous piggyback (IVPB) over 2 hours, leucovorin calcium IVPB over 2 hours, and bevacizumab IVPB over 30 minutes on day 1 and fluorouracil via intravenous (IV) push over 5 minutes and then IV continuously over 46 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBevacizumabGiven IVPB
DRUGFluorouracilGiven IV
DRUGLeucovorin CalciumGiven IVPB
DRUGOxaliplatinGiven IVPB
DRUGRiluzoleGiven PO

Timeline

Start date
2021-04-02
Primary completion
2023-04-04
Completion
2023-05-06
First posted
2021-02-21
Last updated
2025-03-28

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04761614. Inclusion in this directory is not an endorsement.