Status:
TERMINATED
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
University of Malaya
Collaborating Sponsors:
Merck Serono International SA
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 EG...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01230476
Start Date
May 1 2010
End Date
May 1 2015
Last Update
October 7 2019
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100