Head and Neck CancerPhase 2NCT01312493
Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab
A Phase 2 study testing Panitumumab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck. 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?
- Panitumumab and Intensity Modulated Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2018
- 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
- Histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III, IVA, or IVB disease (locally advanced with no systemic metastases and without bilateral nodal disease, i.e., N2c).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 with a life expectancy >12 months.
- Patients are eligible if they have concurrent medical conditions that render them poor candidates for chemotherapy. Patients are considered to be in this group if any of the following criteria is met: Serum creatinine >1.5 mg/dl (or estimated creatinine clearance <50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline phosphatase >2.5 x upper limit of normal; History of significant CAD (myocardial infarction [MI], coronary artery bypass graft [CABG], coronary stents, symptomatic angina); Congestive heart failure [CHF] (LVEF <40% by echocardiogram or MUGA); nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic obstructive pulmonary disease [COPD], defined as FEV1 <1L; In the opinion of the treating physician, patient would not tolerate the administration of concurrent chemotherapy and radiation
- Age >18 years.
- The patient is medically fit to tolerate a course of definitive RT.
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- The patient has adequate hematologic function defined as: absolute neutrophil count >1000/ml, hematocrit >24%, and platelet count >50,000/ml. Patients with hematocrit between 20% and 24% should undergo transfusion, and may be enrolled provided their hematocrit reaches >24%.
- The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
- The patient must agree to use effective contraception if childbearing potential exists and continue contraception for at least 6 months following completion of the study.
- Evaluation by dental services prior to initiation of radiation therapy.
- Patient must be informed of the investigational nature of the study and sign an informed consent form.
Who cannot join
- The patient has received radiation therapy previously to the head and neck. NOTE: Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap significantly.
- All gross disease has been surgically resected. NOTE: Patients who have had an excisional neck biopsy will not be eligible.
- Patient with positive contralateral neck node whether ipsilateral neck is negative or positive.
- The patient is pregnant or lactating.
- Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
- Non-squamous histologies (such as adenoid cystic or mucoepidermoid carcinoma).
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- Spindle cell squamous carcinoma or mixed carcinoma/sarcoma.
- Scleroderma or active connective tissue disorder (Lupus).
- Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
- Major surgery <3 weeks prior to study entry.
- History of interstitial lung disease, e.g., pulmonary fibrosis or interstitial pneumonitis.
About this study
This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.
Read the detailed description
This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?
- Conditions
- Head and Neck Cancer
- Being tested
- Panitumumab, Intensity Modulated Radiation Therapy
- Keywords
- Head and neck cancer, Phase II, Locally advanced, Panitumumab, Vectibix, Lineberger, Radiation Therapy, Intensity modulated radiation therapy (IMRT), Stage III to IVB
- 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.
PanitumumabDrug
Also called Vectibix
Weekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
The dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate of Locally Advanced Head & Neck Cancer
Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
Measured: 2 Years
Secondary outcomes (3)
Patterns of Failure
Evaluate locoregional recurrences to see if they arise in regions that were spared vs. treated, and assess long-term control after salvage therapy.
Measured: 2 Years
Time to Relapse
Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
Measured: first day of therapy to the first sign of progressive disease
Morbidity of Treatment
Toxicity will be assessed according to the NCI CTCAE v4.
Measured: From screening until 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Funding source was terminated before enrollment of first subject
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.
- More trials run by UNC Lineberger Comprehensive 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Neil Hayes, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312493
- Sponsor's protocol ID
- LCCC 1017
- Status last verified
- Aug 2015
- First submitted
- 8 Mar 2011
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab
- ClinicalTrials.gov ID
- NCT01312493
- Acronym / sponsor ID
- LCCC 1017
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, Phase II, Locally advanced, Panitumumab, Vectibix, Lineberger, Radiation Therapy, Intensity modulated radiation therapy (IMRT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding source was terminated before enrollment of first subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Dec 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Mar 2011 (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 non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.
Detailed description
This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III, IVA, or IVB disease (locally advanced with no systemic metastases and without bilateral nodal disease, i.e., N2c).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 with a life expectancy >12 months.
- Patients are eligible if they have concurrent medical conditions that render them poor candidates for chemotherapy. Patients are considered to be in this group if any of the following criteria is met: Serum creatinine >1.5 mg/dl (or estimated creatinine clearance <50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline phosphatase >2.5 x upper limit of normal; History of significant CAD (myocardial infarction [MI], coronary artery bypass graft [CABG], coronary stents, symptomatic angina); Congestive heart failure [CHF] (LVEF <40% by echocardiogram or MUGA); nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic obstructive pulmonary disease [COPD], defined as FEV1 <1L; In the opinion of the treating physician, patient would not tolerate the administration of concurrent chemotherapy and radiation
- Age >18 years.
Key exclusion criteria (11 listed)
- The patient has received radiation therapy previously to the head and neck. NOTE: Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap significantly.
- All gross disease has been surgically resected. NOTE: Patients who have had an excisional neck biopsy will not be eligible.
- Patient with positive contralateral neck node whether ipsilateral neck is negative or positive.
- The patient is pregnant or lactating.
- Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
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 |
|---|---|---|
| PanitumumabAlso: VectibixWeekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments. | Drug | – |
| Intensity Modulated Radiation TherapyAlso: IMRTThe dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks. | Radiation | – |
Primary outcome
Recurrence Rate of Locally Advanced Head & Neck Cancer
Time frame: 2 Years
Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
3 secondary outcomes
Patterns of Failure
Time frame: 2 Years
Time to Relapse
Time frame: first day of therapy to the first sign of progressive disease
Morbidity of Treatment
Time frame: From screening until 30 days after treatment
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 28 Aug 2015.
- UNC Lineberger Comprehensive Cancer Center HomepageLink provided by the sponsor.
- National Cancer Institute HomepageLink 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.
Neil Hayes, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center.
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: withdrawn, as of the sponsor's last update on 28 Aug 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?
Recurrence Rate of Locally Advanced Head & Neck Cancer (time frame: 2 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 28 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.