Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited
• Collaborators: Merck Sharp & Dohme Corp.; Roche Pharma AG; Sanofi; The University of Hong Kong
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

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