Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT00910117
First received: May 28, 2009
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.


Condition Intervention Phase
Head and Neck Cancer
Drug: nimotuzumab
Drug: PF regimen (cisplatin and 5-FU)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pathologic complete response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nimotuzumab
nimotuzumab plus PF regimen
Drug: nimotuzumab
nimotuzumab 400 mg d1
Other Name: h-R3
Drug: PF regimen (cisplatin and 5-FU)
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Other Name: PF

Detailed Description:

Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 18-70 years old
  • ECOG performance status 0-1
  • Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
  • Adequate organ function

Exclusion Criteria:

  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • Previous serious cardiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910117

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

No publications provided

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT00910117     History of Changes
Other Study ID Numbers: HNTG 09-01
Study First Received: May 28, 2009
Last Updated: February 16, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
HNSCC
induction chemotherapy
nimotuzumab

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014