What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as cetuximab (an EGFR inhibitor) and palbociclib (a CDK 4/6 inhibitor), have distinct side effect profiles. Cetuximab can cause severe skin reactions, hypomagnesemia, and infusion-related reactions. Palbociclib is associated with fatigue, neutropenia, infections, and gastrointestinal issues. Patients undergoing these treatments should be closely monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

Cetuximab, an EGFR inhibitor, has been FDA-approved for the treatment of metastatic colorectal cancer, particularly in patients with KRAS wild-type tumors. It works by targeting the epidermal growth factor receptor, thereby inhibiting tumor growth. Palbociclib, a CDK 4/6 inhibitor, is primarily approved for breast cancer but is currently being studied for its potential use in colorectal cancer. These treatments represent targeted therapeutic approaches aimed at specific molecular pathways involved in cancer progression.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment include immune checkpoint inhibitors like pembrolizumab, which has shown efficacy in various cancers including colorectal cancer. Additionally, targeted therapies such as panitumumab (another EGFR inhibitor) and regorafenib (a multi-kinase inhibitor) are also being explored. Combination therapies involving bevacizumab (an anti-VEGF antibody) with chemotherapy regimens like FOLFOX or FOLFIRI are also promising. These alternatives offer new avenues for treatment beyond Cetuximab and Palbociclib.

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Monoclonal Antibodies

Palbociclib + Cetuximab for Colon Cancer

Phase 2

Waitlist Available

Led By Michael Lee

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

4.1.8 Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained prior to initiating study medications. System Laboratory Value Hematological* Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1500/mm3 Platelets ≥ 100,000/mm3 Renal* Creatinine OR Calculated creatinine clearance ≤1.5 x ULN 60 mL/min by Cockcroft-Gault formula Hepatic* Bilirubin ≤ 1.0 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 3 × ULN OR 5 × ULN (if liver metastases present) Alanine aminotransferase (ALT) ≤ 3 × ULN OR 5 × ULN (if liver metastases present) Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.

4.1.3 ECOG Performance Status of 0-2

Must not have

Active infection requiring systemic therapy.

Prior treatment with drug targeting cyclin-dependent kinase (CDK) family.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months (cycle 5)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, cetuximab and palbociclib, to treat patients with advanced colon cancer. The drugs work together to block cancer cell growth and division. The study focuses on patients whose cancer has specific protein characteristics and who have either not been treated with similar drugs before or have developed resistance after initial treatment.

Who is the study for?

Adults with metastatic colorectal cancer who've had at least two prior chemotherapy regimens can join this trial. They must not be pregnant, able to swallow pills, and have no major surgeries in the last 4 weeks. Participants need normal organ function tests and cannot have active infections or CNS metastases. Prior CDK inhibitor treatment is a disqualifier.

What is being tested?

The study is testing the combination of Palbociclib (a drug that inhibits certain proteins) and Cetuximab (an antibody that targets cancer cells) in patients with advanced colon cancer to see if it's effective.

What are the potential side effects?

Possible side effects include allergic reactions, especially in certain U.S. regions due to galactose-alpha-1,3-galactose IgE presence; liver issues; blood disorders like low hemoglobin or platelets; kidney problems indicated by creatinine levels; and heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My colorectal cancer has spread and this was confirmed by a tissue test.

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I can swallow pills without any issues.

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I have not received cetuximab, panitumumab, or similar treatments.

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I've had at least two chemotherapy treatments for my advanced cancer, including specific drugs.

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I do not have the alpha-gal allergy.

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I have not received treatments like cetuximab or panitumumab.

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I can swallow pills without any issues.

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My cancer is wild-type for KRAS, NRAS, and BRAF genes.

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My colorectal cancer has spread and was confirmed by a lab test.

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I am 18 years old or older.

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My cancer is wild-type for KRAS, NRAS, and BRAF genes.

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I've had at least two treatments for my advanced cancer, including specific chemotherapy drugs.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have been treated with a drug targeting CDK before.

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I am not taking any medications or treatments that are not allowed in this study.

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I do not have serious heart conditions like severe chest pain, irregular heartbeat, or a recent heart attack.

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I have not had serious heart problems in the last 6 months.

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I have a history of long-QT syndrome.

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I have active cancer spread to my brain or spinal cord.

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I have had interstitial lung disease or pneumonitis.

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I do not have any severe, uncontrolled health conditions alongside my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months (cycle 5)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months (cycle 5)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months (cycle 5) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate

Secondary study objectives

Length of Overall Survival

Length of Progression Free Survival

Number of Participants With Grade 3 and Grade 4 Adverse Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label, single arm, Phase IIExperimental Treatment2 Interventions

Cetuximab and palbociclib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3790

Cetuximab

2011

Completed Phase 3

~2480

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which is often overexpressed in colorectal cancer cells. By inhibiting EGFR, Cetuximab disrupts cell signaling pathways that promote tumor growth and survival. Palbociclib, on the other hand, inhibits cyclin-dependent kinases 4 and 6 (CDK 4/6), which are crucial for cell cycle progression. By blocking these kinases, Palbociclib induces cell cycle arrest, thereby preventing cancer cell proliferation. These mechanisms are significant for colorectal cancer patients as they offer targeted approaches to halt tumor growth and improve treatment outcomes.

Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Highlights from the 42nd annual meeting of the American Society of Clinical Oncology Atlanta, GA, USA, 2-6 June 2006.