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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will study the effects of cetuximab and palbociclib when used together to treat patients with metastatic colon cancer.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Control Rate

Secondary outcome measures

Length of Overall Survival

Length of progression free survival

Overall Response rate

+1 more

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

~3760

Cetuximab

2011

Completed Phase 3

~2480

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,308 Total Patients Enrolled

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,664 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,849 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03446157 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the prerequisites for participating in this clinical trial?

"In order to be accepted into this research trial, prospective patients must possess colon neoplasms and fall within the age bracket of 18-99. Presently there is a need for 57 participants."

Answered by AI

What other exploratory studies have been carried out with Palbociclib?

"At this time, 247 separate clinical trials are actively exploring the efficacy of Palbociclib. Of those studies, 45 have reached the final phase while 12085 medical facilities around the world are hosting research for Palbociclib. Notably, some investigations in Dresden and Arizona involve this medication."

Answered by AI

Does this experiment seek elderly participants aged 75 or more?

"To be eligible for this trial, subjects must fall between 18 and 99 years old. Additionally, there are 317 trials available to participants who are under the age of majority and 2651 clinical studies offering treatments to those over 65."

Answered by AI

What medical conditions is Palbociclib typically employed to treat?

"Palbociclib is a frequently prescribed therapeutic for radiation therapy. Additionally, it has been used to treat several conditions such as metastatic squamous cell carcinoma of the head and neck (hnscc) or any squamous cells cancer that has been diagnosed by an FDA-approved test."

Answered by AI

Has Palbociclib been granted authorization by the Food and Drug Administration?

"Our team has rated Palbociclib as a 2, which implies that there is clinical evidence of safety with this drug, but not yet efficacy due to it being in the second phase."

Answered by AI

Are there current opportunities to volunteer for this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this experiment is still enrolling patients and was initially shared publicly on March 13th 2018. The study necessitates 57 persons from one site to complete it completely."

Answered by AI

How many individuals have been enrolled in this clinical trial thus far?

"Indeed, records on clinicaltrials.gov demonstrate that this trial is open for recruitment and has been since March 13th 2018. It was last updated on January 25th 2022 with a goal to include 57 patients at a single site in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palbociclib and Cetuximab in Metastatic Colorectal Cancer

2018. "Palbociclib and Cetuximab in Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03446157.

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