Clinical trial NCT01326559: Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)
Official title: Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: induction chemotherapy
docetaxel
cisplatin
fluorouracil
cetuximab
intensity-modulated radiotherapy
Lead sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Sanofi
name: Merck Sharp & Dohme LLC
name: Roche Pharma AG
First posted: 2011-03-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Objective:

Primary

1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).

Secondary

1. To determine the overall response rate.
2. To determine the locoregional and distant control rate
3. To determine the progression-free survival (PFS)
4. To determine the overall survival (OS)
5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.


Eligibility criteria: Inclusion criteria:

* Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy
* Age \> 18 to \< 70 years
* Performance status: \< 1 by ECOG System (Appendix I)
* Adequate bone marrow \& renal function
* Patients having Bilirubin =\< 1.5 x ULN, ASAT \& ALST=\< 1.5 x ULN, Serum creatinine=\< 1.25 x ULN and / or Creatinine clearance \>= 60ml/min
* Patients having WBC \>= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets \>= 100 x10e9/L,Hemoglobin \>=10g/dL
* Signed written informed consent
* Patients must have at least one measurable lesion

Exclusion Criteria:

* Use of investigational agent within the past 28 days
* Pre-treatment with an anti-EGFR drug
* Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
* History of severe pulmonary diseases
* Active infection or other systemic disease under poor control
* Uncontrolled chronic neuropathy
* Know grade 3 or 4 allergic reaction to any of the components of the treatment
* Estimated life expectancy is less than 3 months
* Pregnancy or breast feeding

Primary outcomes:
measure: Complete response rate
timeFrame: 5 years
Secondary outcomes:
measure: Overall response rate
timeFrame: 5 years
measure: Locoregional and distant control rate
timeFrame: 5 years
measure: Progression free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Queen Mary Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong
city: Hong Kong
country: China
facility: Department of Oncology, Princess Margaret Hospital
Study officials:
affiliation: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
name: Lee Anne W.M., F.R.C.R.(HK)
role: PRINCIPAL_INVESTIGATOR
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