Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Conditions

• Head and Neck Squamous Carcinoma

Eligibility Criteria

Sex

ALL

Age

20 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  375mg/m2 on Day-14 and Day-7
• Cisplatin — DRUG
  70mg/m2 on Day1
• Gemcitabine — DRUG
  1000mg/m2 on Day8

Study Details

Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. For recurrent or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given by health insurance for the patients of the situation. A lot of investigations recently showed the B lymphocytes got involvements in the squamous cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the possibility to develop a new treatment policy. Therefore investigators create a pilot clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent or metastatic HNSCC.

Key Dates

Start date

May 31, 2013

Status verified

Apr 2020

Primary completion

Nov 30, 2016

Completion

Jan 31, 2017

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab plus chemotherapy
  * Drug:Rituximab * Drug:Cisplatin * Drug:Gemcitabine

Primary Outcome Measure

feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC [ Time Frame: One week after Rituximab and chemotherapy administration. ]