Palbociclib + Cetuximab for Colon Cancer

Palo Alto (17 mi)

Hanna K. Sanoff, MD, MPH - Division of ...

Overseen byMichael Lee

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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.

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

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

I can swallow pills without any issues.

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

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

I do not have the alpha-gal allergy.

I have not received treatments like cetuximab or panitumumab.

I can swallow pills without any issues.

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

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

I am 18 years old or older.

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

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

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

Exclusion Criteria

I am currently being treated for an infection.

I have been treated with a drug targeting CDK before.

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

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

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

I have a history of long-QT syndrome.

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

I have had interstitial lung disease or pneumonitis.

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

Treatment Details

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.

1Treatment groups

Experimental Treatment

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

Cetuximab and palbociclib

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

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: