FOLFOXIRI + Panitumumab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of medications, including Oxaliplatin (Eloxatin) and Panitumumab (Vectibix), to treat advanced colorectal cancer not previously treated with systemic therapy. The researchers aim to evaluate the effectiveness of this combination in managing cancer that has spread. Suitable candidates for this trial include individuals with a confirmed diagnosis of advanced colon or rectal cancer untreated for metastasis. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in cancer treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining FOLFOXIRI with panitumumab yields mixed safety results. In earlier studies, serious side effects of panitumumab included diarrhea in 25% of patients and skin rashes in about 14%. These side effects can be quite severe.
Another study with a similar treatment found that almost all patients experienced some skin issues, with about a third facing severe ones. Neutropenia, a drop in white blood cells that can lead to infections, affected about 15.6% of patients.
Despite these severe side effects, researchers continue to study these treatments for their potential benefits in colorectal cancer. It is important to consider these risks and discuss with a healthcare provider to decide if joining a trial is appropriate.12345Why do researchers think this study treatment might be promising for colorectal cancer?
Researchers are excited about the treatment involving FOLFOXIRI combined with Panitumumab for colorectal cancer because it offers a novel approach by integrating a targeted therapy with chemotherapy. Unlike standard treatments that typically rely on chemotherapy alone, Panitumumab is an antibody that specifically targets the epidermal growth factor receptor (EGFR), potentially improving the effectiveness of the chemotherapy regimen. This combination has the potential to more precisely attack cancer cells while sparing healthy cells, potentially leading to better outcomes and fewer side effects for patients.
What evidence suggests that FOLFOXIRI + Panitumumab might be an effective treatment for colorectal cancer?
This trial will evaluate the combination of FOLFOXIRI and panitumumab for colorectal cancer. Studies have shown that this combination might not always be the best first option for patients with certain genetic traits. Specifically, research found that it didn't work better for patients with specific types of advanced colorectal cancer. However, when panitumumab is combined with other chemotherapy drugs, it has extended survival compared to chemotherapy alone. For patients with tumors on the left side of the colon, adding panitumumab increased survival to 37.9 months, compared to 34.3 months with other treatments. This suggests potential benefits, depending on the cancer's specific characteristics.12567
Who Is on the Research Team?
Howard Hochster, MD
Principal Investigator
Lead Site PI
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FOLFOXIRI and panitumumab as first-line therapy for metastatic left-sided, RAS WT CRC
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxaliplatin
- Panitumumab
Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Criterium, Inc.
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London