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NCT00910117 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00910117
Other study ID # HNTG 09-01
Secondary ID
Status Completed
Phase Phase 2
First received May 28, 2009
Last updated February 16, 2012
Start date May 2009
Est. completion date December 2011

Study information
Verified date February 2012
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nimotuzumab
nimotuzumab 400 mg d1
• PF regimen (cisplatin and 5-FU)
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5

Locations
Country Name City State
China Fudan University Cancer Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall response rate 6 weeks No
Secondary pathologic complete response 8 weeks No
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