RECRUITING

Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

Conditions

Chordoma Metastatic Chordoma Unresectable Chordoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

Official Title

A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma

Quick Facts

Study Start:2022-05-27

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05041127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years * Histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic * ECOG Performance Status of ≤ 2 * At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 30 days of Day 1 of study. * Adequate organ function within 28 days of Day 1 of study defined as: * The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL * The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L) (NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper Page 26 limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases). * The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). 3.1.6 Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy. * Patients should be completely recovered from any reversible toxicities associated with any prior therapies. * There should be access of archival tumor tissue for central pathology review, or a new tumor related biopsy should be considered within acceptable risk to the patient. * Patients must have no prior history of use of an EGFR inhibitor for treatment of their chordoma * Because the teratogenicity of cetuximab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative serum pregnancy test ≤ seven days prior to Day 1 of study. * Life expectancy of \> 3 months	* Prior use of an EGFR inhibitor for treatment of their chordoma * Non-metastatic, resectable disease * No measurable disease according to RECIST 1.1 * Life expectancy of less than 3 months * Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. * Concomitant participation to another clinical trial with active agent during the study (concomitant non-interventional study will be allowed) Page 27 * Patients who have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, red meat allergy, or tick bite history * Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol * The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency. * The patient has uncontrolled or poorly-controlled hypertension (\>180 mmHg systolic or \> 130 mmHg diastolic. * Major surgery within 4 weeks prior to Day 1 of study or who have not recovered adequately from prior surgery * Patients who have received wide field radiotherapy ≤ 3 weeks or limited field radiation for palliation \< 3 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy * Patients who have received any prior systemic therapy \< 3 weeks prior to Day 1 of study or have not recovered adequately from toxicities to the baseline. * Women who are pregnant or nursing/breastfeeding. * Inability to comply with protocol required procedures such as Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years
* Histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic
* ECOG Performance Status of ≤ 2
* At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 30 days of Day 1 of study.
* Adequate organ function within 28 days of Day 1 of study defined as:
* The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL
* The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L) (NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper Page 26 limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
* The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). 3.1.6 Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy.
* Patients should be completely recovered from any reversible toxicities associated with any prior therapies.
* There should be access of archival tumor tissue for central pathology review, or a new tumor related biopsy should be considered within acceptable risk to the patient.
* Patients must have no prior history of use of an EGFR inhibitor for treatment of their chordoma
* Because the teratogenicity of cetuximab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative serum pregnancy test ≤ seven days prior to Day 1 of study.
* Life expectancy of \> 3 months

* Prior use of an EGFR inhibitor for treatment of their chordoma
* Non-metastatic, resectable disease
* No measurable disease according to RECIST 1.1
* Life expectancy of less than 3 months
* Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
* Concomitant participation to another clinical trial with active agent during the study (concomitant non-interventional study will be allowed) Page 27
* Patients who have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, red meat allergy, or tick bite history
* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
* The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
* The patient has uncontrolled or poorly-controlled hypertension (\>180 mmHg systolic or \> 130 mmHg diastolic.
* Major surgery within 4 weeks prior to Day 1 of study or who have not recovered adequately from prior surgery
* Patients who have received wide field radiotherapy ≤ 3 weeks or limited field radiation for palliation \< 3 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy
* Patients who have received any prior systemic therapy \< 3 weeks prior to Day 1 of study or have not recovered adequately from toxicities to the baseline.
* Women who are pregnant or nursing/breastfeeding.
* Inability to comply with protocol required procedures such as Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.

Contacts and Locations

Study Contact

Anthony Conley, MD

CONTACT

713-796-3626

aconley@mdanderson.org

Principal Investigator

Anthony P Conley, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Anthony P Conley, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-27

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-05-27

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Chordoma
Metastatic Chordoma
Unresectable Chordoma