Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer - Full Text View

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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)

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

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 Provincial 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 May 16, 2013