NCT00891904

Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 12, 2014

Completed
Last Updated

April 14, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

April 30, 2009

Results QC Date

January 29, 2014

Last Update Submit

March 14, 2016

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Outcome Measures

Primary Outcomes (1)

  • Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30

    Daily while on Treatment

Secondary Outcomes (3)

  • Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients

    2 years

  • Local and Distant Control

    very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.

  • Overall Survival

    very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter

Study Arms (1)

Cetuximab

EXPERIMENTAL

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5

Biological: cetuximabRadiation: stereotactic body radiation therapy

Interventions

cetuximabBIOLOGICAL

Given IV

Cetuximab
stereotactic body radiation therapyRADIATION

Undergoing Radiotherapy

Cetuximab

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx * Medically or surgically inoperable disease or patient refuses surgery * Recurrent disease * Previously irradiated disease meeting the following criteria: * Prior radiotherapy completed \> 6 months from re-irradiation * Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields * Majority of the recurrent tumor volume (\> 50%) received prior radiotherapy dose of 30-75 Gy * No distant metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment * No prior allergic reaction to study drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior surgical resection of the recurrent primary tumor and/or regional lymphatics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabRadiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsRadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

Trial terminated early. Too few patients to analyze.

Results Point of Contact

Title
Senior Administrator, Compliance - Clinical Research Services
Organization
Roswell Park Cancer Institute
716-845-2300

Study Officials

  • Anurag K. Singh, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Last Updated

April 14, 2016

Results First Posted

March 12, 2014

Record last verified: 2016-03

Locations

US(1)