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

This study has been completed.
Sponsor:
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
Guangxi Medical University
Central South University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00700440
First received: June 17, 2008
Last updated: March 9, 2010
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: C225 (cetuximab)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Drug: C225 (cetuximab)
one week before and then weekly during radiotherapy
Other Name: Erbitux

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700440

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
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
Guangxi Medical University
Central South University
Investigators
Principal Investigator: Tai-xiang Lu, M.D. Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
Principal Investigator: Tong-yu Lin, M.D., PhD Departments of Chemotherapy, Cancer Center, Sun Yat-sen University
  More Information

Additional Information:
Publications:
Responsible Party: Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00700440     History of Changes
Other Study ID Numbers: EMR62202-770, PPRA-RTOG 0001
Study First Received: June 17, 2008
Results First Received: January 11, 2010
Last Updated: March 9, 2010
Health Authority: China: Ethics Committee
China: Ministry of Health
China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Radiotherapy
chemotherapy
Drug Targeting
loco-regionally advanced nasopharyngeal carcinoma
Safety.
efficacy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014