Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    15
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 18 June 2022
See if I qualify
ct scan
renal function
absolute neutrophil count
measurable disease
x-rays
gilbert's disease
neutrophil count
EGFR
pet/ct
metastatic chordoma

Summary

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.

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

Details
Condition Chordoma, Metastatic Chordoma, Unresectable Chordoma
Treatment Cetuximab, questionnaire administration
Clinical Study IdentifierNCT05041127
SponsorM.D. Anderson Cancer Center
Last Modified on18 June 2022

Eligibility

 Yes No Not Sure

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/L, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/L
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 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)
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) 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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