Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

This study is currently recruiting participants.
Verified April 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Collaborators:
Fudan University
Tongji University
Second Military Medical University
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01440270
First received: September 22, 2011
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

Epidermal growth factor receptor(EGFR) is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.


Condition Intervention Phase
Locally Advanced Malignant Neoplasm
Oral Cancer
Oropharyngeal Carcinoma
Drug: Neo-adjuvant Erbitux-based chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Pathological Complete Response [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.


Secondary Outcome Measures:
  • Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Disease Free Survival (DFS) rates (1, 2, 3, 5 years)

  • Locoregional Control rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Locoregional Control rates (LCR) (1, 3, 5 years)

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall Survival (OS) rate (3, 5 years)

  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    All Adverse Events(AEs),including Serious Adverse Events(SAEs),Exposure of All study drugs & radiation


Estimated Enrollment: 121
Study Start Date: July 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neo-adjuvant Erbitux-based chemotherapy
Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.
Drug: Neo-adjuvant Erbitux-based chemotherapy

Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks

Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Arms: Neo-adjuvant Erbitux-based chemotherapy

Other Name: Followed by surgery and radiotherapy

Detailed Description:

The primary endpoint of this study is the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1, 3, 5 years), overall survival rate (3, 5 years), and the safety.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any study activities
  • Age 18-75
  • Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
  • Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
  • Karnofsky performance status (KPS) ≥ 70
  • Adequate hematologic function: Neutrophils ≥ 1,500/mm^3, WBC > 4,000/mm^3, Hb > 10 g/dL, platelet count > 100,000/mm^3
  • Hepatic function: ALAT/ASAT < 2.5 times the upper limit of normal (ULN), bilirubin < 1.5 x ULN
  • Renal function: serum creatinine < 1.5 x ULN
  • Life expectancy ≥ 6 months

Exclusion Criteria:

  • Evidence of distant metastatic disease and other oropharyngeal cancers
  • Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
  • 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 adequately treated 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
  • Creatinine Clearance < 30 ml/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 cardiac disease such as heart failure, clinically relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440270

Contacts
Contact: Chen-ping Zhang, MD +86-21-23271699 ext 5161 zhang.chenping@hotmail.com

Locations
China, Shanghai
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China
Contact: Lai-ping Zhong, MD, PhD    +86-21-23271699 ext 5160    zhonglaiping@163.com   
Principal Investigator: Lai-ping Zhong, MD, PhD         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Qing-hai Ji         
Principal Investigator: Qing-hai Ji         
Eye & Ear Hospital of Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Liang Zhou         
Principal Investigator: Liang Zhou         
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: Pin Dong         
Principal Investigator: Pin Dong         
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China
Contact: Yun-fu Zhao         
Principal Investigator: Yun-fu Zhao         
Tongji University Dongfang Hospital Active, not recruiting
Shanghai, Shanghai, China
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Ji-fang Ren         
Principal Investigator: Ji-fang Ren         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Fudan University
Tongji University
Second Military Medical University
Investigators
Study Chair: Chen-ping Zhang, MD, PhD Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
  More Information

No publications provided

Responsible Party: Lai-ping Zhong, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01440270     History of Changes
Other Study ID Numbers: EMR 622022237
Study First Received: September 22, 2011
Last Updated: April 5, 2012
Health Authority: China: Ethics Committee
China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Oral cancer
Oropharyngeal cancer
Induction chemotherapy
Targeted chemotherapy
Surgery
Radiotherapy
Effects of Chemotherapy

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

ClinicalTrials.gov processed this record on April 16, 2014