Panitumumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen byJohn H Strickler

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.

Eligibility Criteria

Adults with RAS wild-type colorectal cancer that has spread and/or can't be surgically removed, who have tried anti-EGFR therapy for at least 3 months. They must have good organ function, no major mutations in certain genes, and agree to use contraception. Excluded are those with specific gene mutations or amplifications, prior treatment with both TAS-102 and regorafenib, inability to swallow tablets, uncontrolled illnesses or conditions that could affect the trial's outcomes.

Inclusion Criteria

You had a blood test called Guardant360 within the last 90 days before starting the study.

My white blood cell count is healthy without needing medication.

I am currently taking or have taken Irinotecan.

+31 more

Exclusion Criteria

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

I have a serious wound or fracture that is not healing.

I have not had severe bleeding in the last 4 weeks.

+24 more

Participant Groups

The trial is testing if panitumumab retreatment is more effective than standard treatments (regorafenib or TAS-102) for metastatic colorectal cancer without resistance mutations. Panitumumab may inhibit tumor growth by blocking growth factors; regorafenib might stop tumors by interfering with these factors; TAS-102 aims to kill or halt cancer cell division.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (panitumumab)Experimental Treatment3 Interventions

Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (regorafenib, trifluridine and tipiracil hydrochloride)Active Control4 Interventions

Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Vectibix for: