Clinical trial NCT01230476: Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Official title: Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Locally advanced nasopharyngeal carcinoma
Neoadjuvant chemotherapy
Chemoradiation
Cetuximab
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2010-10-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Inpatients or outpatients, 18-65 years of age
* Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
* Evidence of unidimensional measurable disease as per RECIST criteria
* No systemic metastatic disease (M0)
* ECOG performance status of 0 or 1 at study entry
* Effective contraception
* White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
* Total bilirubin ≤ 1.5x upper reference range
* AST \& ALT ≤ 1.5x upper reference range
* Glomerular filtration rate \> 60 ml/min
* Serum creatinine ≤ 1.25x upper reference range

Exclusion Criteria:

* Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
* Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
* Known hypersensitivity reaction to any of the components of study treatments
* Pregnancy or lactation period
* Systemic metastatic disease
* Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Peripheral neuropathy \> grade 1
* Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
* Known alcohol or drug abuse
* Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
* Legal incapacity or limited legal capacity

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 year
measure: Progression and overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Gwo Fuang Ho, FRCR
role: PRINCIPAL_INVESTIGATOR
References: