Riluzole + Chemotherapy for Colorectal Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ning Jin

Must not be taking: Investigational agents

Disqualifiers: Hepatitis B/C, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

13 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive riluzole orally twice daily on days 1-14, and chemotherapy drugs including oxaliplatin, leucovorin calcium, and bevacizumab on day 1, with fluorouracil administered over days 1-2. Treatment repeats every 2 weeks for up to 8 cycles.

16 weeks

8 cycles, each cycle is 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Bevacizumab
• Fluorouracil
• Leucovorin Calcium
• Oxaliplatin
• Riluzole

Trial Overview The 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

Group I: Treatment (riluzole, mFOLFOX6, bevacizumab) Experimental Treatment 5 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 European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

Ning Jin

Lead Sponsor

Trials

1

Recruited

10+