A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma
Overview
- Phase
- Phase 2
- Intervention
- Cetuximab
- Conditions
- Chordoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Overall response rate
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
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
Investigators
Eligibility Criteria
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.
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.
Arms & Interventions
Treatment (cetuximab)
Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
Intervention: Cetuximab
Treatment (cetuximab)
Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
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.