Head and NeckPhase 2NCT00661427
Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
A Phase 2 study testing cetuximab in people with Head and Neck and Squamous Cell Cancer, run by Memorial Sloan Kettering Cancer Center at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck, Squamous Cell Cancer
- What is being tested?
- cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2007to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07939
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725
City of Hope National Medical Center
Duarte, California, 91010-3000
NorthShore University Health System
Evanston, Illinois, 60201
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Fox Chase Virtua Health Cancer Program
Philadelphia, Pennsylvania, 08060
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York
Huntsman Cancer Institue
Salt Lake City, Utah, 84112
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffit Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m^2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.
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.
- Conditions
- Head and Neck, Squamous Cell Cancer
- Being tested
- cetuximab
- Keywords
- Head and Neck cancer, Cetuximab
- Medical subject headings
- Neoplasms, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
Also called Erbitux
Cetuximab 500 mg/m^2 IV over 2 hours every other week
cetuximabBiological
Also called Erbitux
Cetuximab 750 mg/m^2 IV over 3 hours every other week
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab 500 mg/m^2 | Active comparator | Cetuximab 500 mg/m^2 IV over 2 hours every other week Receives: Biological: cetuximab |
| Cetuximab 750 mg/m^2 | Active comparator | Cetuximab 750 mg/m^2 IV over 3 hours every other week Receives: Biological: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately every 8 weeks with imaging up to two years
Secondary outcomes (1)
The Total Number of Participants That Were Effected by Adverse Events.
Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.
Measured: at least weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and NeckStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Matthew Fury, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661427
- Sponsor's protocol ID
- 08-039
- Status last verified
- Dec 2017
- First submitted
- 7 Jan 2008
- Last updated
- 11 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m^2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.
- ClinicalTrials.gov ID
- NCT00661427
- Acronym / sponsor ID
- 08-039
- Conditions
- Head and Neck, Squamous Cell Cancer
- Keywords
- Head and Neck cancer, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, National Comprehensive Cancer Network
- Study start
- Nov 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab 500 mg/m^2 | Active comparator | Biological: cetuximabCetuximab 500 mg/m^2 IV over 2 hours every other week |
| Cetuximab 750 mg/m^2 | Active comparator | Biological: cetuximabCetuximab 750 mg/m^2 IV over 3 hours every other week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetuximabAlso: ErbituxCetuximab 500 mg/m^2 IV over 2 hours every other week | Biological | Cetuximab 500 mg/m^2 |
| cetuximabAlso: ErbituxCetuximab 750 mg/m^2 IV over 3 hours every other week | Biological | Cetuximab 750 mg/m^2 |
Primary outcome
Number of Patients With Overall Objective Response
Time frame: Approximately every 8 weeks with imaging up to two years
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
1 secondary outcome
The Total Number of Participants That Were Effected by Adverse Events.
Time frame: at least weekly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Fury, MD,PhD principal investigator
Memorial Sloan Kettering Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab in people with Head and Neck and Squamous Cell Cancer, run by Memorial Sloan Kettering Cancer Center at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Overall Objective Response (time frame: Approximately every 8 weeks with imaging up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.