Study on Panitumumab With or Without Trametinib for Stage IV Colorectal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03087071

Provider View

This clinical trial is exploring whether the drug panitumumab, alone or combined with trametinib, can effectively treat patients with advanced colorectal cancer. The study aims to see if these treatments can help the immune system fight cancer and stop tumor growth.

Patient Parameters

Program Overview

This phase II study is testing how well panitumumab, with or without trametinib, works in treating patients with stage IV colorectal cancer. Panitumumab is a type of immunotherapy that may help the immune system attack cancer cells and prevent them from growing and spreading. Trametinib may help stop tumor growth by blocking certain enzymes needed for cell growth. The study is investigating if using these drugs together or separately is more effective for patients with advanced colorectal cancer.

Description

The main goals of this study are to see how effective panitumumab is on its own and in combination with trametinib for patients with advanced colorectal cancer. The study focuses on patients who have specific genetic markers and have previously been treated with anti-EGFR therapy. Researchers want to understand how these treatments work in patients with different genetic mutations and to evaluate any side effects.

Patients are divided into three groups based on their genetic mutations:

  • Group 1: Patients with a specific EGFR mutation receive panitumumab through an IV every two weeks. If their cancer progresses, they may switch to Group 2.
  • Group 2: Patients with KRAS, NRAS, or BRAF mutations take trametinib daily and receive panitumumab every two weeks.
  • Group 3: Patients without specific mutations receive panitumumab every two weeks. If their cancer progresses, they may switch to Group 2.

After completing the study treatment, patients will be monitored for four weeks and then every three months for two years.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed stage IV colorectal cancer that has spread.
  • Cancer must have progressed during or shortly after specific chemotherapy treatments.
  • Must have specific genetic markers (wild-type KRAS, NRAS, BRAF) confirmed by tests.
  • Must have been previously treated with anti-EGFR therapy and shown some benefit.
  • Must have measurable cancer according to standard criteria.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate blood counts and organ function based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
  • Must be able to swallow pills and have no significant digestive issues.
  • Must have specific genetic mutations detected in circulating tumor DNA for certain groups.

Exclusion Criteria

  • Previous treatment with MEK or ERK inhibitors.
  • Retreatment with anti-EGFR therapy after initial progression.
  • Untreated or recently treated brain metastases.
  • History of lung disease or pneumonitis.
  • Recent history of other cancers, except for certain skin or cervical cancers.
  • Recent major surgery or other cancer treatments.
  • Significant heart problems or uncontrolled high blood pressure.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • History of organ transplant or immune system issues.
  • Known allergies to study drugs or related substances.
  • Current infections with HIV, hepatitis B, or hepatitis C.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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