Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01074021
First received: February 21, 2010
Last updated: August 26, 2010
Last verified: September 2009
  Purpose

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.


Condition Intervention Phase
Advanced Nasopharyngeal Cancer
Drug: Nimotuzumab
Drug: placebo plus chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer

Resource links provided by NLM:


Further study details as provided by Biotech Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation [ Time Frame: 3 months after the Nimotuzumab treatment finished ] [ Designated as safety issue: No ]
  • To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3 [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: October 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimotuzumab plus chemoradiotherapy Drug: Nimotuzumab

Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy)

Radiotherapy:

IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.

CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin

Chemotherapy:

Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)

Placebo Comparator: placebo plus chemoradiotherapy Drug: placebo plus chemoradiotherapy

Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy

Radiotherapy:

IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.

CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin

Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)


Detailed Description:

Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Joined the study voluntary and signed informed consent form
  • Age 18-70,both genders.
  • Nasopharyngeal cancer was confirmed by pathology.
  • Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
  • Primary lesions can measurable.
  • Karnofsky Performance Scale >70.
  • Life expectancy of more than 6 months.
  • Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
  • Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
  • Hepatic function:ALAT、ASAT< 1.5 x ULN, TBIL< 1.5 x ULN
  • Renal function: Creatinine < 1.5 x ULN

Exclusion Criteria:

  • Evidence of distant metastasis
  • Primary lesions or lymph node have been operated (except of operation for biopsy)
  • Previous radiotherapy
  • Received other anti EGFR monoclonal antibody treatment
  • Previous chemotherapy or immunization therapy
  • Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
  • Participation in other interventional clinical trials within 1 month
  • Peripheral neuropathy is more than I stage
  • Pregnant or breast-feeding women and women who refused to take contraceptive method
  • History of serious allergic or allergy
  • History of Serious lung or heart disease
  • Refused or can't signed informed consent form
  • Drug abuse or alcohol addiction
  • Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct
  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: NCT01074021

  Show 32 Study Locations
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jianji Pan Fujian Cancer Hospital
  More Information

No publications provided

Responsible Party: Jianji-Pan, Fujian Provincial Cancer Hospital
ClinicalTrials.gov Identifier: NCT01074021     History of Changes
Other Study ID Numbers: BT-CT-001
Study First Received: February 21, 2010
Last Updated: August 26, 2010
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
Nimotuzumab
Nasopharyngeal cancer
chemoradiation

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014