Head and Neck Squamous Cell CancerNCT01790516
Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
A study testing Cisplatin, cetuximab and Radiation in people with Head and Neck Squamous Cell Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery. The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. 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?
- Cisplatin, cetuximab and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2013
- Phase
- Interventional
- 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
- Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
- Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
- No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
- Eastern Cooperative Oncology Group performance status </= 1
- Women of child-bearing potential must have a negative pregnancy test within 30 hours before initiation of study drug dosing. Female subjects of reproductive potential must agree to avoid pregnancy throughout the study and for up to 3 months following discontinuation of study drug. Male subjects must agree to avoid conceiving a child throughout the study and for up to 3 months following discontinuation of study drug;
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- Hemoglobin >/= 8.0 gm/dL
- Absolute neutrophil count >/= 1500
- Platelet count >/= 100,000
- Glomerular Filtration Rate > 50 mL/min calculated by the Cockcroft-Gault equation
- Total bilirubin </= 2.0 times the upper limit of normal unless the patient has Gilbert's syndrome
- Aspartate aminotransferase and Alanine Aminotransferase </= 2.5 times the upper limit of normal
- No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for >/= 3 years prior to screening for this protocol.
- Age of 18 or older
- Ability and willingness to give informed consent
- Subjects must in the opinion of the Investigator be capable of complying with this protocol.
Who cannot join
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Major surgery within 3 weeks prior to study entry
- Known hypersensitivity to cisplatin or cetuximab
- Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction </= 6 months prior to study entry.
- Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
- Patients unwilling to comply with the protocol, or provide informed consent
- Psychiatric illness that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Lombardi Comprhensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Prospective Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery.
The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.
Read the detailed description
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B).
The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.
- Conditions
- Head and Neck Squamous Cell Cancer
- Keywords
- Head and neck cancer, genetic testing, cisplatin, erbitux, radiation therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Cispaltin, Platinum
Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
cetuximabDrug
Also called Erbitux
Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
RadiationRadiation
daily radiation for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | Cisplatin Receives: Drug: Cisplatin; Radiation: Radiation |
| Cetuximab | Experimental | cetuximab Receives: Drug: cetuximab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician
Feasibility is defined as follows:
- Patients' genetic test results are returned to the treating physician within 3 days
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionJun 2013
Why it stopped: low accruals--2 patients were enrolled in over a year
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 Neck Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F Deeken, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790516
- Sponsor's protocol ID
- 2010-439
- Status last verified
- Oct 2013
- First submitted
- 21 Jun 2012
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01790516
- Acronym / sponsor ID
- 2010-439
- Conditions
- Head and Neck Squamous Cell Cancer
- Keywords
- Head and neck cancer, genetic testing, cisplatin, erbitux, radiation therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accruals--2 patients were enrolled in over a year
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery.
The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.
Detailed description
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B).
The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: Cisplatin, Radiation: RadiationCisplatin |
| Cetuximab | Experimental | Drug: cetuximab, Radiation: Radiationcetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
- Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
- No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
- Eastern Cooperative Oncology Group performance status </= 1
Key exclusion criteria (7 listed)
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Major surgery within 3 weeks prior to study entry
- Known hypersensitivity to cisplatin or cetuximab
- Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction </= 6 months prior to study entry.
- Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
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 |
|---|---|---|
| CisplatinAlso: Cispaltin, PlatinumCisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy | Drug | Cisplatin |
| cetuximabAlso: ErbituxCetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation. | Drug | Cetuximab |
| Radiationdaily radiation for 7 weeks | Radiation | Cetuximab, Cisplatin |
Primary outcome
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician
Time frame: 20 months
Feasibility is defined as follows: - Patients' genetic test results are returned to the treating physician within 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John F Deeken, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisplatin, cetuximab and Radiation in people with Head and Neck Squamous Cell Cancer, run by Georgetown University at 1 site 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 16 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2014). 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?
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician (time frame: 20 months). 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 2 Oct 2014.