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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hong Kong Nasopharyngeal Cancer Study Group Limited.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The University of Hong Kong
Sanofi
Merck Sharp & Dohme Corp.
Roche Pharma AG
Information provided by (Responsible Party):
Dr. ANNE W M LEE, Hong Kong Nasopharyngeal Cancer Study Group Limited
ClinicalTrials.gov Identifier:
NCT01326559
First received: March 22, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hong Kong Nasopharyngeal Cancer Study Group Limited:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.

  • Locoregional and distant control rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Defined as the proportion of subjects with no local or nodal progression or recurrence and no distant disease progression or recurrence compared to the overall treated group.

  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Defined as the time in months from first dose of cetuximab until PD is observed or death occurs due to any cause within 90 days after the last tumour assessment or first cetuximab dose.

  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Defined as the time in months from first dose of cetuximab to the date of death is observed. If subject has not died, the survival time will be censored on the last date the subject was known to be alive.


Estimated Enrollment: 41
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1
Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16
Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab

Induction phase (Weeks 1-9):

Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles

Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles

Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles

Concurrent phase (weeks 10-16):

Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16)

Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16)

IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326559

Contacts
Contact: Lee Anne W.M., FRCR (HK) 852-25954173 awmlee@ha.org.hk

Locations
China
Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong Recruiting
Hong Kong, China
Contact: Ngan Roger K.C., F.R.C.    852-29586255    ngankc@ha.org.hk   
Principal Investigator: Ngan Roger, F.R.C.R         
Department of Clinical Oncology, Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Kwong Dora, F.R.C.R    852-28554521    dlwkwong@hkucc.hku.hk   
Principal Investigator: Kwong Dora, F.R.C.R         
Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong Recruiting
Hong Kong, China
Contact: Tung Stewart Y., F.R.C.R    852-24685087    tungys@ha.org.hk   
Principal Investigator: Tung Stewart Y., F.R.C.R         
Department of Oncology, Princess Margaret Hospital Recruiting
Hong Kong, China
Contact: Yau C.C, F.R.C.R    852-29902803    ccyau@ha.org.hk   
Principal Investigator: Yau C.C, F.R.C.R         
Sponsors and Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
The University of Hong Kong
Sanofi
Merck Sharp & Dohme Corp.
Roche Pharma AG
Investigators
Principal Investigator: Lee Anne W.M., F.R.C.R.(HK) Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
  More Information

Publications:

Responsible Party: Dr. ANNE W M LEE, Chief of Service, Dept of Clinical Oncology, PYNEH, Hong Kong Nasopharyngeal Cancer Study Group Limited
ClinicalTrials.gov Identifier: NCT01326559     History of Changes
Other Study ID Numbers: NPC-1001 trial
Study First Received: March 22, 2011
Last Updated: September 5, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee

Keywords provided by Hong Kong Nasopharyngeal Cancer Study Group Limited:
induction chemotherapy
docetaxel
cisplatin
fluorouracil
cetuximab
intensity-modulated radiotherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014