Triple Therapy for Advanced Solid Cancers

Recruiting in Palo Alto (17 mi)

David S Hong | MD Anderson Cancer Center

Overseen ByDavid Hong, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of vemurafenib when given together with cetuximab and irinotecan hydrochloride in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Vemurafenib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib with cetuximab and irinotecan hydrochloride may be a better treatment for solid tumors.

Eligibility Criteria

This trial is for patients with solid tumors that have spread or can't be surgically removed, and who have a specific BRAF V600 mutation. They should not have received recent tumor treatment, must be able to swallow pills, and agree to use contraception. Those with severe medical conditions or certain heart issues are excluded.

Inclusion Criteria

My cancer has a BRAF V600 mutation.

I can take care of myself and am up and about more than half of my waking hours.

My cancer has spread and cannot be removed with surgery.

My tumor is K-RAS wild-type.

My liver function tests are within the required limits.

Exclusion Criteria

I have fluid buildup in my chest or heart area that hasn't been treated.

My heart's electrical activity or electrolyte levels are abnormal.

I cannot swallow pills.

I am currently undergoing chemotherapy.

I have not fully recovered from surgery within the last 4 weeks.

I am not taking strong medication that affects liver enzyme CYP3A4.

My cancer is BRAF wild-type.

My cancer has a K-RAS mutation detected by an FDA-approved test.

I do not have any severe illnesses like ongoing infections or bowel blockages.

I have severe heart failure or unstable chest pain.

Participant Groups

The trial tests the combination of vemurafenib, cetuximab, and irinotecan hydrochloride on patients with advanced solid tumors. It aims to find the safest dose while assessing how these drugs affect tumor growth by blocking enzymes and boosting the immune system's response.

1Treatment groups

Experimental Treatment

Group I: Treatment (vemurafenib, cetuximab, irinotecan hydrochloride)Experimental Treatment5 Interventions

Patients receive vemurafenib PO BID on days 1-14, cetuximab IV over 90 minutes, and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: