Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

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This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab

400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy

Group Type EXPERIMENTAL

C225 (cetuximab)

Intervention Type DRUG

one week before and then weekly during radiotherapy

Interventions

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C225 (cetuximab)

one week before and then weekly during radiotherapy

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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Inclusion Criteria

* Informed consent form signed prior to study entry
* Age between 18-69 years old
* Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
* Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
* Primary tumor measurable
* KPS score ≥80
* Expected life span ≥6 months
* Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
* Adequate liver function: ALAT/ASAT\<1.5 × upper limit of normal (ULN), bilirubin \<1.5×ULN
* Adequate renal function: Creatinine Clearance \< 1.5×ULN

Exclusion Criteria

* Evidence of distant metastatic disease
* Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
* Previous radiotherapy for the primary tumor or lymph nodes
* Previous exposure to epidermal growth factor-targeted therapy
* Prior chemotherapy or immunotherapy for the primary tumor
* Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
* Any investigational agent prior to the 1st study medication
* Participation in another clinical study within the 30 days prior to Inclusion in this study.
* Peripheral neuropathy \> grade 1
* Known grade 3 or 4 allergic reaction to any of the study treatment
* History of severe pulmonary or cardiac disease
* Creatinine Clearance \< 30ml/min
* Know drug abuse / alcohol abuse
* Legal incapacity or limited legal capacity
* Active systemic infection
* Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
* Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period
* Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No