Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

NCT01434394 | Completed Phase 2 DMC

• 2 other identifiers: 9thShanghai10DZ1951300
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Malignant Neoplasm; Oral Cancer; Oropharyngeal Carcinoma; Effects of Chemotherapy

Keywords

Oral cancer; Oropharyngeal cancer; Induction chemotherapy; Targeted chemotherapy; Surgery; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response

  To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.

  Up to 6 months

Secondary Outcomes (4)

• Disease Free Survival

  5 years

• Locoregional Control rates

  5 years

• Overall Survival

  5 years

• Number of Participants with Adverse Events

  5 years

Study Arms (2)

Neo-adjuvant Erbitux-based chemotherapy

EXPERIMENTAL

Neo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, Docetaxel, Cisplatin.

Drug: Neo-adjuvant Erbitux-based chemotherapy

Surgery and radiotherapy

NO INTERVENTION

Surgery and post-operative radiotherapy.

Interventions

Neo-adjuvant Erbitux-based chemotherapy DRUG

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)

Also known as: Followed by surgery and radiotherapy

Neo-adjuvant Erbitux-based chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 non-melanoma skin cancer or pre-invasive carcinoma of the cervix
• Any investigational agent prior to the 1st study medication
• 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 \<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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Fudan University: collaborator
• Tongji University: collaborator
• Second Military Medical University: collaborator

Study Sites (1)

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chen-ping Zhang, MD, PhD

  Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ninth People's Hospital, School of Medicine

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 14, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2014-05

Locations

CN (1)