Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

NCT01326923 | Terminated Phase 2 Results DMC

• 1 other identifier: H10-109
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.

Conditions

Head and Neck Squamous Cell Cancer

Keywords

Head; Neck; Locally advanced; Squamous Cell; Hypopharynx; Larynx; Oral Cavity; Base of Tongue; Tonsil; Neck lymph node; Resection

Outcome Measures

Primary Outcomes (1)

• Complete Response

  Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

  Analysis at Week 26

Secondary Outcomes (1)

• Progression Free Survival

  Analysis at Week 26

Study Arms (1)

Single arm

OTHER

Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

Drug: Cetuximab

Interventions

Cetuximab DRUG

Single arm phase II study of chemotherapy

Also known as: Single arm phase II study

Single arm

Eligibility Criteria

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

You may qualify if:

• Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis
• A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:
• Hypopharynx: The tumor must extend across the midline of the posterior pharyngeal wall or be fixed to the cervical spine
• Larynx: There must by either direct extension into surrounding muscle or skin or greater than 3 cm of sub-glottic extension
• Oral cavity: The lesion must be so extensive that a functional reconstruction is not possible.
• Base of Tongue: The tumor must extend into the roof of tongue, or the patient must refuse a recommended total glossectomy
• Tonsil: The tumor must extend into the pterygoid region as manifested by clinical trismus or demonstrated across the midline of the pharyngeal wall or directly into soft tissue of the neck
• Patients with neck lymph node metastases fixed to the carotid artery, the mastoid, the base of the skull, or the cervical spine are considered un-resectable
• Medical unsuitability for resection is not sufficient for patient eligibility
• Patient's refusal for surgery except in case of total glossectomy is not considered a reason for unresectibility
• Patients must have received no prior treatment for head and neck cancer
• ECOG Performance status 0-1
• Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)
• leukocytes \> 3,000/mcL
• absolute neutrophil count \> 1,500/mcL

You may not qualify if:

• Patient who have had prior treatment for head and neck cancer
• Prior history of radiation to head and neck area
• Known malignancy other than the current cancer
• Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements
• Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
• Patient with documented or symptoms of peripheral neuropathy
• History of allergic reaction to compounds similar to the ones used in this study
• Any condition that would hamper ability to give informed consent or ability to comply with study protocol
• HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: J.K. Miller
• Organization: LSU Health Shreveport

jmil12@lsuhsc.edu

318 8131406

Study Officials

• Syed H Jafri, MB,B,S

  LSU shreveport

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, FWCC

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 31, 2011
• Study Start: June 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Locations

US (1)