Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

Nasopharyngeal Carcinoma Clinical Trial

— ENCORE  

Official title:

Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700440
• Other study ID #: EMR62202-770
• Secondary ID: PPRA-RTOG 0001
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: March 9, 2010
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Informed consent form signed prior to study entry

• Age between 18-69 years old

• Pathology approved to be nasopharyngeal carcinoma (types WHO ?-?)

• Stage ?, ?a, ?b 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 ß-HCG) or lactation period

• Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• C225 (cetuximab)
one week before and then weekly during radiotherapy

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Guizhou Province, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Central South University, First Affiliated Hospital of Guangxi Medical University, Fudan University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Erratum in: J Clin Oncol. 2006 Feb 1;24(4):724. — View 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. Erratum in: J Clin Oncol. 2007 Aug 20;25(24):3790. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy	The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.; Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.	3 months	Yes
Secondary	1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival		5 year	No

External Links

•   Home Page of Chinese Anti-Cancer Association