Study on Palbociclib and Cetuximab for Treating Metastatic Colorectal Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03446157

Provider View

This clinical trial is exploring the combination of two drugs, cetuximab and palbociclib, to see if they can effectively treat metastatic colorectal cancer. Cetuximab is already used for this type of cancer, while palbociclib is being tested for its potential benefits.

Patient Parameters

Program Overview

The purpose of this study is to understand how well the combination of cetuximab and palbociclib works in treating metastatic colorectal cancer. Cetuximab is a drug that targets a protein called EGFR, which helps cancer cells grow. Palbociclib is another drug that targets a different protein involved in cell growth. By using these drugs together, researchers hope to improve treatment outcomes for patients whose cancer has specific characteristics that make it more likely to respond to this combination.

Description

This study is testing a combination of two drugs, cetuximab and palbociclib, for treating metastatic colorectal cancer. Cetuximab is an antibody that targets a protein called EGFR, which is important for cancer cell growth. It helps the immune system recognize and attack cancer cells. Palbociclib is a drug that targets proteins involved in cell division, slowing down or stopping cancer cell growth. While cetuximab is already approved for colorectal cancer, palbociclib is being tested in this study to see if it can enhance the effects of cetuximab.

Participants in this study must have colorectal cancer with normal KRAS, NRAS, and BRAF proteins, as these cancers are more likely to respond to cetuximab. The study will include two groups: one that has not been treated with EGFR inhibitors like cetuximab, and another that has previously responded to such treatments but then developed resistance. Researchers aim to see if the combination of cetuximab and palbociclib can overcome this resistance and improve treatment outcomes.

The study will also explore whether using these drugs together provides a stronger anti-cancer effect than using them separately. By targeting multiple processes in cancer cells, the combination may offer a more effective treatment option.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic colorectal cancer.
  • Have cancer that can be measured by scans.
  • Cancer must have normal KRAS, NRAS, and BRAF proteins.
  • Have been treated with at least two prior chemotherapy regimens for advanced cancer.
  • Have adequate organ function based on blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use contraception if their partners are of childbearing potential.
  • Be able to swallow capsules and have no conditions that prevent taking oral medications.
  • Have not had major surgery in the past four weeks.
  • For certain locations, must test negative for a specific allergy related to cetuximab.
  • For one group, must not have had prior treatment with cetuximab or similar drugs.
  • For another group, must have previously responded to cetuximab or similar drugs for at least four months and have not received such treatment in the past eight weeks.

Exclusion Criteria

  • Have an active infection requiring treatment.
  • Are pregnant or breastfeeding.
  • Have cancer that has spread to the brain.
  • Have taken an investigational drug in the past 28 days.
  • Have been treated with drugs targeting CDK proteins.
  • Are taking medications that cannot be stopped and are not allowed in the study.
  • Have allergies to the study drugs.
  • Have another active cancer requiring treatment.
  • Have uncontrolled health conditions like severe heart or lung disease.
  • Have a history of lung disease or heart conditions that affect heart rhythm.
  • Have a psychiatric or substance abuse disorder that affects study participation.
  • Are taking drugs that affect heart rhythm, with some exceptions.

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