Cetuximab for Treating Advanced or Spread Chordoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05041127
This clinical trial is testing the effectiveness and safety of the drug cetuximab for adults with advanced or metastatic chordoma, a type of cancer that cannot be surgically removed or has spread to other parts of the body.
Patient Parameters
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Program Overview
This study is being conducted at multiple centers and involves patients with advanced or metastatic chordoma. The main goal is to see how well cetuximab works in shrinking tumors and to assess its safety for patients. Participants must be 18 years or older and have chordoma that cannot be surgically removed or has spread.
Description
The primary aim of this study is to determine how effective cetuximab is in treating advanced or metastatic chordoma by measuring the response rate of tumors. Secondary goals include evaluating the response using different criteria, assessing the safety and tolerability of cetuximab, and measuring how long patients live without the disease getting worse and their overall survival. The study will also compare the time patients live without disease progression on cetuximab to their previous treatments.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of chordoma that is advanced or has spread.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2.
- Have at least one tumor that can be measured by scans.
- Have adequate organ function based on specific blood tests.
- Must not have used an EGFR inhibitor for chordoma treatment before.
- Must have a life expectancy of more than 3 months.
- Must have a tumor sample available for review or be willing to undergo a biopsy.
- Must not be pregnant and agree to use effective birth control if sexually active.
- Must have recovered from any previous treatments and have a washout period of at least 3 weeks from any prior therapies.
Exclusion Criteria
- Have used an EGFR inhibitor for chordoma treatment before.
- Have chordoma that can be surgically removed or is not metastatic.
- Have no measurable disease according to specific criteria.
- Have a life expectancy of less than 3 months.
- Have had another invasive cancer within the last 2 years, except for certain non-invasive cancers.
- Be participating in another clinical trial with an active treatment.
- Have a history of severe allergic reactions to similar drugs or red meat allergy.
- Have severe or uncontrolled medical conditions that pose safety risks.
- Have significant heart disease or uncontrolled high blood pressure.
- Have had major surgery within the last 4 weeks or not recovered from prior surgery.
- Have received recent radiation or systemic therapy without adequate recovery.
- Be pregnant or breastfeeding.
- Be unable to comply with study procedures due to medical or other conditions.
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