A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

NCT01435252 | Completed Phase 2 DMC

• 1 other identifier: Add-On cetuximab
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled in this study. Patients are treated with standard chemoradiation in combination with concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control rate.

• Trial with medicinal product
• Trial with radiotherapy

Conditions

Oropharyngeal Cancer; Hypopharyngeal Cancer; Laryngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Locoregional tumor control

  2 years

Secondary Outcomes (6)

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Metastasis rate

  2 years

• Metastasis free survival (MFS)

  2 years

• Biological surrogate markers

  2 years

Study Arms (2)

Arm A

EXPERIMENTAL

Patients will be treated with chemoradiation in combination with concurrent cetuximab. Two weeks after end of chemoradiation the consolidation phase will start and patients will receive biweekly consolidation cetuximab, maximally 6 infusions over 12 weeks.

Drug: Cetuximab

Arm B

EXPERIMENTAL

Patients will be treated with chemoradiation in combination with concurrent cetuximab.

Drug: Cetuximab

Interventions

Cetuximab DRUG

Arm A: chemoradiation in combination with concurrent cetuximab Arm B: chemoradiation in combination with concurrent and consolidation cetuximab

Also known as: Erbitux®

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• T3-4 Nx M0; Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved) and/or total GTV \> 70 cc (any T, any N, M0)
• biopsy proven squamous cell cancer
• primary tumor location in oral cavity, oropharynx, hypopharynx or larynx
• Patients with CUP (cancer of unknown primary) syndrome in case they have advanced lymph node metastases (Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved).- Indication for chemoradiation (RT + Cisplatin)
• curative treatment intent
• Start of chemoradiation within the recruitment time frame
• Performance Status WHO/ECOG: 0-1
• Age between 18 and 75 years
• No previous chemotherapy or RT for cancer of the head and neck
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment
• Patient must sign informed consent prior to study entry.

You may not qualify if:

• Cancer of the nasopharynx
• Any neoadjuvant chemotherapy prior to screening
• Treatment with other investigational drugs within 4 weeks
• History of malignancy other than basal cell skin cancer unless disease free for a minimum of 3 years.
• Uncontrolled claudication, bleeding, or thromboembolic disorders at screening
• Patients receiving heparin, warfarin or phenprocoumon therapy are ineligible- Uncontrolled and severe hypertension at screening according to the judgement of the investigator.
• Current uncontrolled cardiac disease: Unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, history of myocardial infarction within 12 months, significant arrhythmias
• Left ventricular function \< 45 % (determination of left ventricular function required when history of cardiac disease)
• History of stroke within 6 months
• Major surgical procedure, or significant traumatic injury within 28 days prior to screening; anticipation of need for major surgical procedure during the course of the study.
• Acute bacterial or fungal infection requiring intravenous antibiotics at screening
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at screening
• Pregnant (positive pregnancy test) or lactating
• Previous organ transplantation
• Any immune suppressive therapy

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital

Zurich, Switzerland

Location

Related Publications (1)

• de Galiza Barbosa F, Riesterer O, Tanadini-Lang S, Stieb S, Studer G, Pruschy M, Huber GF, Huellner MW, Stolzmann P, Veit-Haibach P. Evaluation of 18F-FDG PET/CT as an early imaging biomarker for response monitoring after radiochemotherapy using cetuximab in head and heck squamous cell carcinoma. Head Neck. 2020 Feb;42(2):163-170. doi: 10.1002/hed.25975. Epub 2019 Nov 9.

  PMID: 31705729 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Oliver Riesterer, Leitender Arzt

  University Hospital Zurich, Division of Radiation Oncology

  PRINCIPAL INVESTIGATOR

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: Leitender Arzt

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: September 16, 2011
• Study Start: September 19, 2011
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CH (1)