NCT00661427

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed
Last Updated

January 11, 2018

Status Verified

December 1, 2017

Enrollment Period

4.8 years

First QC Date

January 7, 2008

Results QC Date

October 19, 2015

Last Update Submit

December 11, 2017

Conditions

Head and NeckSquamous Cell Cancer

Keywords

Head and Neck cancerCetuximab

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Overall Objective Response

    Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam

    Approximately every 8 weeks with imaging up to two years

Secondary Outcomes (1)

  • The Total Number of Participants That Were Effected by Adverse Events.

    at least weekly

Study Arms (2)

Cetuximab 500 mg/m^2

ACTIVE COMPARATOR

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Biological: cetuximab

Cetuximab 750 mg/m^2

ACTIVE COMPARATOR

Cetuximab 750 mg/m\^2 IV over 3 hours every other week

Biological: cetuximab

Interventions

cetuximabBIOLOGICAL

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Also known as: Erbitux
Cetuximab 500 mg/m^2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent and HIPAA authorization
  • histologically confirmed squamous cell cancer of the head and neck
  • At least 21 days must have elapsed from the administration of prior chemotherapy for recurrent/metastatic disease.
  • measurable disease as defined by RECIST
  • ECOG PS ≤ 2
  • Adequate hematologic function as defined by an ANC \> or = to 1200/mm3 , and a platelet count ≥ 100,000 obtained within 14 days prior to enrollment.
  • Adequate hepatic function as defined by t. bilirubin ≤ 1.5 mg/dl, transaminases \& alk phos ≤ 5x ULN obtained within 14 days prior to enrollment.
  • Adequate renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance \>40 mL/minute.
  • Women of childbearing potential must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study and have a negative pregnancy test within 7 days prior to registration. If a male and sexually active, the patient agrees to use effective contraception.
  • Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.
  • Patients with treated CNS metastases may be eligible if they have fully recovered from radiation therapy, surgery or steroids that were prescribed for CNS metastases.

You may not qualify if:

  • Known, uncontrolled CNS metastases. CT/MRI of the brain is not required unless CNS metastases are suspected clinically.
  • prior cetuximab therapy in the setting of recurrence or refractory disease
  • Other active invasive malignancies, other than non-melanoma skin cancers or in situ cervical cancer.
  • Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, or targeted therapy.
  • Ongoing or active clinically serious infection \> CTCAE Grade 2 requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia,(patients with stable rate-controlled atrial fibrillation may be eligible) or other medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study, or psychiatric illness/social situations that would limit compliance with study requirements.
  • elective or planned major surgery to be performed during the course of the trial
  • pregnant or lactating women
  • employees of the investigator or study center w/ direct involvement in this study or other studies under the direction of the or study center, as well as family member of the employees
  • More than two prior cytotoxic regimens for metastatic/recurrent disease.
  • Known hypersensitivity reaction to mouse antibodies.
  • Patients with nasopharyngeal cancer are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

H. Lee Moffit Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan-Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07939, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Location

Fox Chase Virtua Health Cancer Program

Philadelphia, Pennsylvania, 08060, United States

Location

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Abramson Cancer Center University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38104, United States

Location

Huntsman Cancer Institue

Salt Lake City, Utah, 84112, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms, Squamous CellHead and Neck Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

For safety data please see adverse events

Results Point of Contact

Title
Dr. David Pfister
Organization
Memorial Sloan Kettering Cancer Center
pfisterd@mskcc.org
646-888-4237

Study Officials

  • Matthew Fury, MD,PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

April 18, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 11, 2018

Results First Posted

November 20, 2015

Record last verified: 2017-12

Locations

US(17)