Head and Neck Squamous Cell CancerPhase 2NCT01326923
Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer
A Phase 2 study testing Cetuximab in people with Head and Neck Squamous Cell Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Feb 2014
- 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
- Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis
- A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:
- Hypopharynx: The tumor must extend across the midline of the posterior pharyngeal wall or be fixed to the cervical spine
- Larynx: There must by either direct extension into surrounding muscle or skin or greater than 3 cm of sub-glottic extension
- Oral cavity: The lesion must be so extensive that a functional reconstruction is not possible.
- Base of Tongue: The tumor must extend into the roof of tongue, or the patient must refuse a recommended total glossectomy
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- Tonsil: The tumor must extend into the pterygoid region as manifested by clinical trismus or demonstrated across the midline of the pharyngeal wall or directly into soft tissue of the neck
- Patients with neck lymph node metastases fixed to the carotid artery, the mastoid, the base of the skull, or the cervical spine are considered un-resectable
- Medical unsuitability for resection is not sufficient for patient eligibility
- Patient's refusal for surgery except in case of total glossectomy is not considered a reason for unresectibility
- Patients must have received no prior treatment for head and neck cancer
- ECOG Performance status 0-1
- Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)
- leukocytes > 3,000/mcL
- absolute neutrophil count > 1,500/mcL
- platelets > 100,000/mcL
- total Bilirubin within normal institutional limits
- AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to give informed consent and willingness to adhere to study protocol
- Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
Who cannot join
- Patient who have had prior treatment for head and neck cancer
- Prior history of radiation to head and neck area
- Known malignancy other than the current cancer
- Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements
- Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
- Patient with documented or symptoms of peripheral neuropathy
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- History of allergic reaction to compounds similar to the ones used in this study
- Any condition that would hamper ability to give informed consent or ability to comply with study protocol
- HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
Shreveport, Louisiana, 71103
About this study
Official title: Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer
This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.
Read the detailed description
Chemotherapy:
Chemotherapy would be used in two phases. In the initial phase all patients would be treated with ICT involving 6 cycles of PCC. This involves Cetuximab 400mg/m2 Week 1 and then 250mg/m2 weekly, Paclitaxel 80mg/m2 weekly and carboplatin AUC 2 weekly for 6 weeks followed by concurrent chemoradiotherapy with cetuximab. After ICT patients would be given weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 concurrent with radiation therapy.
Radiation Therapy:
Typically for tumors treated by megavoltage (6MV) radiotherapy alone or with chemotherapy, the primary tumor bed with an adequate margin and the draining lymphatics will be treated with parallel opposed lateral treatment portals; the lower neck node bearing area will be treated through an anterior port. The standard total dose for the targeted tumor bed and electively treated lymphatics is 50 Gy/25 fractions, and then, an additional boost dose to the neoplasm-bearing site(s) of 16 Gy to 20 Gy.
The total dose received by the spinal cord should not be allowed to exceed 46 Gy. For N1 to N3 disease, they also shall need a total dose (boost included) of 66 Gy and perhaps up to 70 Gy if it can be safely given 6.4 Study Outline:
- Patients who are deemed eligible and sign informed consent would be enrolled in the clinical trial.
- Prior to starting therapy staging PET/CT scan, medical history, physical exam, hematologic and biochemical testing will be undertaken.
- Since mucositis and oropharyngeal dysfunction is very likely with chemo-radiation PEG tube placements will be considered prior to treatment, in order to allow adequate nutrition in case of mucositis.
- Prior to starting radiation patients would undergo dental evaluation which is a standard practice.
- Patients would then undergo 6 weeks of ICT using PCC. Based on toxicity dose would be modified as described in section 8.
- For PCC regimen, cetuxmiab would be given first followed by paclitaxel and then carboplatin using standard pre-medication.
- A CT scan (no PET scan) of the head and neck will be performed during the evaluation Week 7 on any day of that week.
- Following induction chemotherapy patients would be treated with radiation therapy of up to 70 Gy concurrent with weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 for the duration of radiation therapy. Again dose modifications would be performed based as described in section 8.
- Cetuximab would be administered first followed by cisplatin concurrent with radiation.
- History and Physical examination would be performed at the end of treatment to document response and assess toxicity
- Patient with residual disease at the primary site or neck after completion of chemoradiotherapy would be offered surgery.
- Week 26 (3 months) after completion of radiation therapy a repeat PET scan will be performed to assess response which is standard of care.
- After completion of all treatment patients will be followed at every 3 months interval to document relapse or manage toxicities from treatment.
- Conditions
- Head and Neck Squamous Cell Cancer
- Being tested
- Cetuximab
- Keywords
- Head, Neck, Locally advanced, Squamous Cell, Hypopharynx, Larynx, Oral Cavity, Base of Tongue, Tonsil, Neck lymph node, Resection
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Single arm phase II study
Single arm phase II study of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Measured: Analysis at Week 26
Secondary outcomes (1)
Progression Free Survival
Improvement in progression free survival (PFS)in locally advanced stage III and IV head and neck cancer patients with sequential (ICT) followed by Concurrent chemo-radiotherapy (CR) using monoclonal antibody Cetuximab as compared to historical controls.
Measured: Analysis at Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Principle Investigator left the institution.
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Mills, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Syed H Jafri, MB,B,S, Principal investigator, LSU shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326923
- Sponsor's protocol ID
- H10-109
- Status last verified
- Sep 2020
- First submitted
- 24 Mar 2011
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT01326923
- Acronym / sponsor ID
- H10-109
- Conditions
- Head and Neck Squamous Cell Cancer
- Keywords
- Head, Neck, Locally advanced, Squamous Cell, Hypopharynx, Larynx, Oral Cavity, Base of Tongue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle Investigator left the institution.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.
Detailed description
Chemotherapy:
Chemotherapy would be used in two phases. In the initial phase all patients would be treated with ICT involving 6 cycles of PCC. This involves Cetuximab 400mg/m2 Week 1 and then 250mg/m2 weekly, Paclitaxel 80mg/m2 weekly and carboplatin AUC 2 weekly for 6 weeks followed by concurrent chemoradiotherapy with cetuximab. After ICT patients would be given weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 concurrent with radiation therapy.
Radiation Therapy:
Typically for tumors treated by megavoltage (6MV) radiotherapy alone or with chemotherapy, the primary tumor bed with an adequate margin and the draining lymphatics will be treated with parallel opposed lateral treatment portals; the lower neck node bearing area will be treated through an anterior port. The standard total dose for the targeted tumor bed and electively treated lymphatics is 50 Gy/25 fractions, and then, an additional boost dose to the neoplasm-bearing site(s) of 16 Gy to 20 Gy.
The total dose received by the spinal cord should not be allowed to exceed 46 Gy. For N1 to N3 disease, they also shall need a total dose (boost included) of 66 Gy and perhaps up to 70 Gy if it can be safely given 6.4 Study Outline:
- Patients who are deemed eligible and sign informed consent would be enrolled in the clinical trial.
- Prior to starting therapy staging PET/CT scan, medical history, physical exam, hematologic and biochemical testing will be undertaken.
- Since mucositis and oropharyngeal dysfunction is very likely with chemo-radiation PEG tube placements will be considered prior to treatment, in order to allow adequate nutrition in case of mucositis.
- Prior to starting radiation patients would undergo dental evaluation which is a standard practice.
- Patients would then undergo 6 weeks of ICT using PCC. Based on toxicity dose would be modified as described in section 8.
- For PCC regimen, cetuxmiab would be given first followed by paclitaxel and then carboplatin using standard pre-medication.
- A CT scan (no PET scan) of the head and neck will be performed during the evaluation Week 7 on any day of that week.
- Following induction chemotherapy patients would be treated with radiation therapy of up to 70 Gy concurrent with weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 for the duration of radiation therapy. Again dose modifications would be performed based as described in section 8.
- Cetuximab would be administered first followed by cisplatin concurrent with radiation.
- History and Physical examination would be performed at the end of treatment to document response and assess toxicity
- Patient with residual disease at the primary site or neck after completion of chemoradiotherapy would be offered surgery.
- Week 26 (3 months) after completion of radiation therapy a repeat PET scan will be performed to assess response which is standard of care.
- After completion of all treatment patients will be followed at every 3 months interval to document relapse or manage toxicities from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: CetuximabSingle arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis
- A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:
- Patients must have received no prior treatment for head and neck cancer
- ECOG Performance status 0-1
- Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)
Key exclusion criteria (9 listed)
- Patient who have had prior treatment for head and neck cancer
- Prior history of radiation to head and neck area
- Known malignancy other than the current cancer
- Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements
- Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
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: Single arm phase II studySingle arm phase II study of chemotherapy | Drug | Single arm |
Primary outcome
Complete Response
Time frame: Analysis at Week 26
Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
1 secondary outcome
Progression Free Survival
Time frame: Analysis at Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- 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.
Syed H Jafri, MB,B,S principal investigator
LSU shreveport
1 site 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 Squamous Cell Cancer, run by Louisiana State University Health Sciences Center Shreveport 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 21 inclusion and 9 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 9 Oct 2020. 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.
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 9 Oct 2020). 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?
Complete Response (time frame: Analysis at Week 26). 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 9 Oct 2020.