- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041127
Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
May 7, 2024 updated by: M.D. Anderson Cancer Center
A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
• To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.
Secondary Objectives:
- To evaluate response rate according to Choi criteria
- To evaluate the safety and tolerability of cetuximab for chordoma patients
- To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
- To evaluate the ratio of PFS on study compared to PFS from prior treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anthony Conley, MD
- Phone Number: 713-796-3626
- Email: aconley@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Anthony P. Conley, MD
- Phone Number: 713-796-3626
- Email: aconley@mdanderson.org
-
Principal Investigator:
- Anthony P. Conley, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (cetuximab)
Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: through study completion, an average of 1 year
|
Measured by Response Evaluation Criteria in Solid Tumors 1.1.
Will be estimated based on a binomial portion expressed as percentage with 95% confidence intervals.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony P Conley, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start (Actual)
May 27, 2022
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
September 2, 2021
First Posted (Actual)
September 10, 2021
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0217 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-14259 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chordoma
-
Jonsson Comprehensive Cancer CenterBristol-Myers SquibbCompletedChordoma | Metastatic Chordoma | Unresectable Chordoma | Locally Advanced ChordomaUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Canon Medical Systems, USANot yet recruitingChordoma of Sacrum | Chordoma of Spine | Chordoma of Skull Base
-
Institut CurieActive, not recruitingSkull Base Chordoma | Vertebral ChordomaFrance
-
Heidelberg UniversityActive, not recruiting
-
Huashan HospitalBoehringer IngelheimNot yet recruiting
-
CNAO National Center of Oncological HadrontherapyDept. of Electronics, Informatics, Bioengineering, Politecnico di Milano,...Recruiting
-
Xuanwu Hospital, BeijingRecruiting
-
Massachusetts General HospitalM.D. Anderson Cancer Center; National Cancer Institute (NCI)Active, not recruitingChordoma of Sacrum | Chordoma of Spine | Chordoma of Base of Skull | Chondrosarcoma of the Spine | Chondrosarcoma of the SacrumUnited States
-
National Cancer Institute (NCI)RecruitingGenes | Sporadic ChordomaUnited States
-
Hospices Civils de LyonRecruitingMalignant Tumors as Chordoma, Adenoid Cystic Carcinoma and SarcomaFrance
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingLi-Fraumeni SyndromeUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Caregiver | Advanced Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
Istituto Auxologico ItalianoCompletedObesity | Eating DisordersItaly
-
Vanderbilt-Ingram Cancer CenterTerminatedMalignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Federico II UniversityUnknownSleep Disorder | Renal Transplant | Hypertension; NephropathyItaly