Head and Neck CancerPhase 2PGx-SELECTNCT00881114
Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer
A Phase 2 study testing Cisplatin and Cetuximab in people with Head and Neck Cancer, run by Georgetown University.
Trial summary
This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cisplatin and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 of the oral cavity, oropharynx, hypopharynx, or larynx
- Locally advanced, Stage III or IVB disease and a candidate for primary therapy using chemotherapy and radiation with curative intent
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is primary modality of treatment
- No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck cancer
- ECOG performance status 0 or 1
- Negative pregnancy test
Show all 15Show fewer
- Hemoglobin >/= 8.0
- Absolute neutrophil count >/= 1500
- Platelet count >/= 100,000
- GFR > 50 mL/min
- Total bilirubin </= 1.5 upper limits of normal
- AST and ALT </= 2.5 times upper limits 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.
- Ability and willingness to give consent
- Subjects must in the opinion of the Investigator be capable of complying with the protocol
Who cannot join
- Primary tumors of the nasopharynx, sinuses, and salivary glands
- 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 or uncontrolled infectious disorder, myocardial infarction </= 6 months prior to study entry
- Psychiatric illness that would limit compliance with study requirements
About this study
Official title: A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. This type of genetic testing is called pharmacogenetics.
Currently there are two drugs used to treat head and neck cancer that have provided a benefit when given with radiation compared to radiation alone in previous studies. These two drugs are cisplatin and cetuximab (Erbitux).
In this trial, the investigators will test whether genetic differences between patients can be used to pick which drug they should receive. A recent study that looked back to see how well patients with head and neck cancer responded to treatment with cisplatin showed that genetic differences in a few genes were associated with who did and who did not survive their cancer. The investigators are taking that finding and using it to test patients for these genetic differences to determine whether they should receive cisplatin or cetuximab. In other words, the investigators are trying to take what is essentially a flip of the coin choice between these two drugs, and instead use individual patient's genetic differences to make-and hopefully improve- this choice.
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 variations at four SNP loci in 3 genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin, while patients with 2 or fewer variants will receive cetuximab.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, pharmacogenetics, chemoradiotherapy
- 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 cis-diamminedichloridoplatinum(II), CDDP
Intensity modulated radiation therapy with concurrent chemotherapy. Cisplatin will be administered at a dose of 100 mg/m2 during weeks 1, 4, and 7 of radiation therapy. Post treatment neck dissection will be performed if clinically indicated.
CetuximabDrug
Also called Erbitux
Intensity modulated Radiation Therapy with concurrent chemotherapy. Cetuximab will be administered beginning at a dose of 400 mg/m2 the week before radiation commences, then at a dose of 250 mg/m2 weekly during weeks 1 to 7. Post treatment neck dissection will be performed if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Experimental | patients with 2 or fewer genetic variants will receive cetuximab Receives: Drug: Cetuximab |
| Cisplatin | Experimental | Subjects with 3 to 8 genetic variants will receive cisplatin Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 36months
Secondary outcomes (4)
Objective response
Measured: 36 months
Overall survival
Measured: 36 months
Toxicity
Measured: 8 weeks
Quality of Life
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2013 (estimated)
Why it stopped: Investigator decided it was not feasible to conduct this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Investigators
- John Deeken, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881114
- Sponsor's protocol ID
- PGx-SELECT
- Other IDs
- 2008-526
- Acronym
- PGx-SELECT
- Status last verified
- Apr 2009
- First submitted
- 13 Apr 2009
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00881114
- Acronym / sponsor ID
- PGx-SELECT / PGx-SELECT
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, pharmacogenetics, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided it was not feasible to conduct this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. This type of genetic testing is called pharmacogenetics.
Currently there are two drugs used to treat head and neck cancer that have provided a benefit when given with radiation compared to radiation alone in previous studies. These two drugs are cisplatin and cetuximab (Erbitux).
In this trial, the investigators will test whether genetic differences between patients can be used to pick which drug they should receive. A recent study that looked back to see how well patients with head and neck cancer responded to treatment with cisplatin showed that genetic differences in a few genes were associated with who did and who did not survive their cancer. The investigators are taking that finding and using it to test patients for these genetic differences to determine whether they should receive cisplatin or cetuximab. In other words, the investigators are trying to take what is essentially a flip of the coin choice between these two drugs, and instead use individual patient's genetic differences to make-and hopefully improve- this choice.
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 variations at four SNP loci in 3 genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin, while patients with 2 or fewer variants will receive cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Experimental | Drug: Cetuximabpatients with 2 or fewer genetic variants will receive cetuximab |
| Cisplatin | Experimental | Drug: CisplatinSubjects with 3 to 8 genetic variants will receive cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy proven squamous cell carcinoma of the head and neck, including of the oral cavity, oropharynx, hypopharynx, or larynx
- Locally advanced, Stage III or IVB disease and a candidate for primary therapy using chemotherapy and radiation with curative intent
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is primary modality of treatment
- No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck cancer
- ECOG performance status 0 or 1
Key exclusion criteria (6 listed)
- Primary tumors of the nasopharynx, sinuses, and salivary glands
- 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 or uncontrolled infectious disorder, myocardial infarction </= 6 months prior to study entry
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: cis-diamminedichloridoplatinum(II), CDDPIntensity modulated radiation therapy with concurrent chemotherapy. Cisplatin will be administered at a dose of 100 mg/m2 during weeks 1, 4, and 7 of radiation therapy. Post treatment neck dissection will be performed if clinically indicated. | Drug | Cisplatin |
| CetuximabAlso: ErbituxIntensity modulated Radiation Therapy with concurrent chemotherapy. Cetuximab will be administered beginning at a dose of 400 mg/m2 the week before radiation commences, then at a dose of 250 mg/m2 weekly during weeks 1 to 7. Post treatment neck dissection will be performed if clinically indicated. | Drug | Cetuximab |
Primary outcome
Progression-free survival
Time frame: 36months
4 secondary outcomes
Objective response
Time frame: 36 months
Overall survival
Time frame: 36 months
Toxicity
Time frame: 8 weeks
Quality of Life
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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 Deeken, MD principal investigator
Georgetown University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Cetuximab in people with Head and Neck Cancer, run by Georgetown University.
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 15 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (time frame: 36months). 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 27 Mar 2015.