Clinical trial NCT00700440: Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Official title: Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Radiotherapy
chemotherapy
Drug Targeting
loco-regionally advanced nasopharyngeal carcinoma
Safety.
efficacy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Sichuan Cancer Hospital and Research Institute
name: Fujian Cancer Hospital
name: Fudan University
name: Cancer Hospital of Guizhou Province
name: First Affiliated Hospital of Guangxi Medical University
name: Central South University
First posted: 2008-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
timeFrame: 3 months
Secondary outcomes:
measure: 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
name: Tai-xiang Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Chemotherapy, Cancer Center, Sun Yat-sen University
name: Tong-yu Lin, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung FL, Poon TC, Hui EP, Ma BB, Liong E, To KF, Huang DP, Chan AT. Antitumor effect and enhancement of cytotoxic drug activity by cetuximab in nasopharyngeal carcinoma cells. In Vivo. 2005 Jan-Feb;19(1):237-45.
citation: 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.
citation: Kiss R, Salmon I, Pauwels O, Gras S, Danguy A, Etievant C, Pasteels JL, Martinez J. In vitro influence of gastrin, oestradiol and gonadotropin-releasing hormone on HCT-15 and LoVo human colorectal neoplastic cell proliferation. Eur J Cancer. 1991;27(10):1268-74. doi: 10.1016/0277-5379(91)90095-u.
citation: Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646.
citation: Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. doi: 10.1200/JCO.2006.08.8005.