Title
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma
Phase
Phase 2Lead Sponsor
Sun Yat-Sen UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Nasopharyngeal CarcinomaIntervention/Treatment
cetuximab ...Study Participants
100This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
one week before and then weekly during radiotherapy
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Inclusion Criteria: Informed consent form signed prior to study entry Age between 18-69 years old Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ) Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria Primary tumor measurable KPS score ≥80 Expected life span ≥6 months Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN Adequate renal function: Creatinine Clearance < 1.5×ULN Exclusion Criteria: Evidence of distant metastatic disease Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) Previous radiotherapy for the primary tumor or lymph nodes Previous exposure to epidermal growth factor-targeted therapy Prior chemotherapy or immunotherapy for the primary tumor Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix Any investigational agent prior to the 1st study medication Participation in another clinical study within the 30 days prior to Inclusion in this study. Peripheral neuropathy > grade 1 Known grade 3 or 4 allergic reaction to any of the study treatment History of severe pulmonary or cardiac disease Creatinine Clearance < 30ml/min Know drug abuse / alcohol abuse Legal incapacity or limited legal capacity Active systemic infection Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol Pregnancy (confirmed by serum or urine β-HCG) or lactation period Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
| Event Type | Organ System | Event Term |
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The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.
Outcome Measure Data Not Reported
