FOLFOXIRI + Panitumumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byHoward Hochster, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Criterium, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a phase II, open-label, non-randomized study in subjects with histologically confirmed diagnosis of left-sided RAS WT advanced adenocarcinoma of the colon or rectum who have not received prior systemic therapy for metastatic disease.

Research Team

Howard Hochster, MD

Principal Investigator

Lead Site PI

Eligibility Criteria

Adults with left-sided RAS wild-type advanced colorectal cancer who haven't had systemic therapy for metastatic disease can join. They must have measurable disease, be in good physical condition (ECOG 0-1), and use effective contraception. Exclusions include pregnancy, breastfeeding, certain past cancers or conditions like lung disease, bleeding disorders, severe allergies to monoclonal antibodies, uncontrolled infections or cardiovascular issues.

Inclusion Criteria

Subjects must have signed an approved informed consent

Calcium ≥ lower limit of normal

Bilirubin ≤ 1.5 x upper limit of normal

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Exclusion Criteria

My blood clotting tests are normal and I've been on a stable dose of blood thinners for at least two weeks.

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

I have only had skin cancer, cervical pre-cancer, or any cancer that hasn't come back in 3 years.

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Treatment Details

Interventions

Oxaliplatin (Alkylating agents)
Panitumumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing the effectiveness of FOLFOXIRI combined with Panitumumab in treating metastatic colorectal cancer on the left side that hasn't spread elsewhere. It's an open-label phase II study where all participants receive the treatment without being randomly assigned to different groups.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

This is an open label study single arm

Oxaliplatin is already approved in Canada, Japan, Switzerland, China for the following indications: