Riluzole + Chemotherapy for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byNing Jin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ning Jin

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding riluzole to standard chemotherapy and bevacizumab can better treat patients with colorectal cancer that has spread. Riluzole may enhance the effectiveness of chemotherapy, which kills or stops cancer cells, while bevacizumab cuts off the tumor's blood supply. Bevacizumab has been shown to improve survival in patients with advanced colorectal cancer when combined with chemotherapy.

Research Team

Ning Jin, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer who can receive mFOLFOX6/bevacizumab and have adequate organ function. They must understand the study, agree to use contraception, and be willing to undergo tumor biopsies. Excluded are those with hepatitis B/C, severe kidney issues, certain heart conditions, uncontrolled blood pressure or illness that affects compliance.

Inclusion Criteria

Serum total bilirubin < 1.5 x ULN

Ability to understand and the willingness to sign a written informed consent document

I am using birth control and have a negative pregnancy test.

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Exclusion Criteria

I have not had extensive radiotherapy in the last 4 weeks or targeted radiotherapy in the last 2 weeks.

My kidney function is severely impaired.

Cardiac conditions as follows: Active coronary artery disease, unstable or newly diagnosed angina or myocardial infarction less than 6 months prior to first study drug administration, Class III-IV New York Heart Association (NYHA) congestive heart failure, Uncontrolled hypertension (Systolic blood pressure [BP] > 150 mmHg and diastolic BP > 90 mmHg for 24 hours) despite optimal medical management, Corrected QT (QTc) (Friderica) prolongation > 480 msec, Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements, Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration, Known inability to swallow capsules, Inability to comply with study and/or follow-up procedures, Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued

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Treatment Details

Interventions

Bevacizumab (Monoclonal Antibodies)
Fluorouracil (Alkylating agents)
Leucovorin Calcium (Folate analogs)
Oxaliplatin (Platinum-containing Compound)
Riluzole (Sodium Channel Blocker)

Trial OverviewThe trial tests riluzole combined with standard chemotherapy (mFOLFOX6) and bevacizumab against metastatic colorectal cancer. It aims to determine the best dose of riluzole and its effectiveness in enhancing chemotherapy's impact on tumor cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (riluzole, mFOLFOX6, bevacizumab)Experimental Treatment5 Interventions

Patients receive riluzole PO BID on days 1-14. Patients also receive oxaliplatin via IVPB over 2 hours, leucovorin calcium IVPB over 2 hours, and bevacizumab IVPB over 30 minutes on day 1 and fluorouracil via 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.

Bevacizumab is already approved in Japan, Canada for the following indications: