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Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
C225 (cetuximab)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Radiotherapy, chemotherapy, Drug Targeting, loco-regionally advanced nasopharyngeal carcinoma, Safety., efficacy

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival

Full Information

First Posted
June 17, 2008
Last Updated
March 9, 2010
Sponsor
Sun Yat-sen University
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sichuan Cancer Hospital and Research Institute, Fujian Cancer Hospital, Fudan University, Cancer Hospital of Guizhou Province, First Affiliated Hospital of Guangxi Medical University, Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT00700440
Brief Title
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Acronym
ENCORE
Official Title
Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Radiotherapy, chemotherapy, Drug Targeting, loco-regionally advanced nasopharyngeal carcinoma, Safety., efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab
Arm Type
Experimental
Arm Description
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Intervention Type
Drug
Intervention Name(s)
C225 (cetuximab)
Other Intervention Name(s)
Erbitux
Intervention Description
one week before and then weekly during radiotherapy
Primary Outcome Measure Information:
Title
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tai-xiang Lu, M.D.
Organizational Affiliation
Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tong-yu Lin, M.D., PhD
Organizational Affiliation
Departments of Chemotherapy, Cancer Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15796181
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.
Results Reference
background
PubMed Identifier
16467544
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.
Results Reference
background
PubMed Identifier
1835597
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.
Results Reference
background
PubMed Identifier
16314626
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. Erratum In: J Clin Oncol. 2006 Feb 1;24(4):724.
Results Reference
background
PubMed Identifier
17538164
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. Erratum In: J Clin Oncol. 2007 Aug 20;25(24):3790.
Results Reference
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Links:
URL
http://www.caca.org.cn/
Description
Home Page of Chinese Anti-Cancer Association

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Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

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