Metastatic Chordoma Clinical Trial
A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
This phase II trial studies the effect of cetuximab in treating patients with chordoma that has spread from its original site of growth to distant anatomic sites and is not amenable to surgical resection (advanced unresectable) or has spread to other parts of the body (metastatic). Cetuximab may interfere with the epidermal growth factor receptor (EGFR) gene, which may cause tumor cells to die.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. SECONDARY OBJECTIVES: I. To evaluate response rate according to Choi criteria. II. To evaluate the safety and tolerability of cetuximab for chordoma patients. III. To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median). IV. To evaluate the ratio of progression-free survival (PFS) on study compared to PFS from prior treatment. EXPLORATORY OBJECTIVES: I. To evaluate the use of a Clinical Laboratory Improvement Act (CLIA)-certified anti-EGFR immuno-stain (clone 31G7, Abnova) on pre-treatment chordoma tissue and determine if quantitative/qualitative presence of EGFR expression is associated with any clinical characteristics observed during the clinical trial. II. To perform a functional proteomic analysis of chordoma tumor samples prior to treatment with cetuximab and on treatment with cetuximab to evaluate for potential biomarkers of resistance and/or response. III. To perform genomic sequencing, including ribonucleic acid (RNA) and deoxyribonucleic acid (DNA), of chordoma tumor samples prior to treatment with cetuximab and on treatment with cetuximab to evaluate for potential biomarkers of resistance and/or response. IV. To evaluate CD16 FcgammaRIIIA status of peripheral blood mononuclear cells (PBMC's) from peripheral blood of each patient at treatment initiation by flow cytometric gating strategies. V. To evaluate quality of life for adult (>= 12 years) chordoma patients on this study using the MD Anderson Symptom Inventory (MDASI), a patient-reported outcome (PRO) measure assessing the severity of symptoms and the interference with daily living as a result of these symptoms. OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once weekly (QW) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and every 3 months for up to 24 months. ;
|Source||M.D. Anderson Cancer Center|
|Status||Not yet recruiting|
|Start date||September 30, 2021|
|Completion date||September 1, 2022|