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

NCT01326559 | Completed Phase 2 DMC

• 1 other identifier: NPC-1001 trial
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

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

Conditions

Nasopharyngeal Carcinoma

Keywords

induction chemotherapy; docetaxel; cisplatin; fluorouracil; cetuximab; intensity-modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.

  5 years

Secondary Outcomes (4)

• Overall response rate

  5 years

• Locoregional and distant control rate

  5 years

• Progression free survival

  5 years

• Overall survival

  5 years

Study Arms (1)

Experimental 1

EXPERIMENTAL

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

Interventions

Docetaxel, Cisplatin, 5-FU and Cetuximab DRUG

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)

Experimental 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Nasopharyngeal Cancer Study Group Limited: lead
• The University of Hong Kong: collaborator
• Sanofi: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Roche Pharma AG: collaborator

Study Sites (4)

Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong

Hong Kong, China

Location

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, China

Location

Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong

Hong Kong, China

Location

Department of Oncology, Princess Margaret Hospital

Hong Kong, China

Location

Related Publications (14)

• Fu KK, Newman H, Phillips TL. Treatment of locally recurrent carcinoma of the nasopharynx. Radiology. 1975 Nov;117(2):425-31. doi: 10.1148/117.2.425.

  PMID: 170644 BACKGROUND

• Pryzant RM, Wendt CD, Delclos L, Peters LJ. Re-treatment of nasopharyngeal carcinoma in 53 patients. Int J Radiat Oncol Biol Phys. 1992;22(5):941-7. doi: 10.1016/0360-3016(92)90792-g.

  PMID: 1555986 BACKGROUND

• Wang CC. Re-irradiation of recurrent nasopharyngeal carcinoma--treatment techniques and results. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):953-6. doi: 10.1016/0360-3016(87)90030-7.

  PMID: 3597157 BACKGROUND

• Teo PM, Kwan WH, Chan AT, Lee WY, King WW, Mok CO. How successful is high-dose (> or = 60 Gy) reirradiation using mainly external beams in salvaging local failures of nasopharyngeal carcinoma? Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):897-913. doi: 10.1016/s0360-3016(97)00854-7.

  PMID: 9531376 BACKGROUND

• Leung TW, Tung SY, Sze WK, Sze WM, Wong VY, Wong CS, O SK. Salvage radiation therapy for locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1331-8. doi: 10.1016/s0360-3016(00)00776-8.

  PMID: 11121630 BACKGROUND

• Poon D, Yap SP, Wong ZW, Cheung YB, Leong SS, Wee J, Tan T, Fong KW, Chua ET, Tan EH. Concurrent chemoradiotherapy in locoregionally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1312-8. doi: 10.1016/j.ijrobp.2004.01.037.

  PMID: 15275714 BACKGROUND

• Yan JH, Hu YH, Gu XZ. Radiation therapy of recurrent nasopharyngeal carcinoma. Report on 219 patients. Acta Radiol Oncol. 1983;22(1):23-8. doi: 10.3109/02841868309134335.

  PMID: 6305129 BACKGROUND

• Lu TX, Mai WY, Teh BS, Zhao C, Han F, Huang Y, Deng XW, Lu LX, Huang SM, Zeng ZF, Lin CG, Lu HH, Chiu JK, Carpenter LS, Grant WH 3rd, Woo SY, Cui NJ, Butler EB. Initial experience using intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):682-7. doi: 10.1016/S0360-3016(03)01508-6.

  PMID: 14967420 BACKGROUND

• Chua DT, Sham JS, Leung LH, Au GK. Re-irradiation of nasopharyngeal carcinoma with intensity-modulated radiotherapy. Radiother Oncol. 2005 Dec;77(3):290-4. doi: 10.1016/j.radonc.2005.10.010. Epub 2005 Nov 8.

  PMID: 16289398 BACKGROUND

• Chua DT, Sham JS, Au GK. Induction chemotherapy with cisplatin and gemcitabine followed by reirradiation for locally recurrent nasopharyngeal carcinoma. Am J Clin Oncol. 2005 Oct;28(5):464-71. doi: 10.1097/01.coc.0000180389.86104.68.

  PMID: 16199985 BACKGROUND

• Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

  PMID: 17960012 BACKGROUND

• Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

  PMID: 16467544 BACKGROUND

• Nakata E, Hunter N, Mason K, Fan Z, Ang KK, Milas L. C225 antiepidermal growth factor receptor antibody enhances the efficacy of docetaxel chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1163-73. doi: 10.1016/j.ijrobp.2004.02.050.

  PMID: 15234052 BACKGROUND

• Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

  PMID: 17960013 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lee Anne W.M., F.R.C.R.(HK)

  Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Service, Dept of Clinical Oncology, PYNEH

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 31, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

CN (4)