Squamous Cell Carcinoma of the Head and NeckPhase 2TOP0901NCT01305772
Identification of Gene Expression Signature for Panitumumab Sensitivity in Untreated Locally Advanced SCCHN
A Phase 2 study testing Panitumumab, Surgery and Radiation Therapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Neal Ready at 2 sites in United States.
Trial summary
The purpose of this study was to identify which cancer-related genes are turned on or turned off in order to determine how well a patient will respond to the study drug, panitumumab. Panitumumab was added to standard adjuvant or primary radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Panitumumab, Surgery and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to May 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
- Untreated, suspected or histologically documented locally advanced clinical stage III or IVa-b(M0)SCCHN, no evidence of distant metastases. Prior surgery with diagnosis of SCCHN acceptable
- Candidate for definitive surgery or radiation based therapy.
- Fresh frozen tumor tissue must be available for genomic analysis and must pass RNA Quality Control prior to research PET/CT #1 and/or initiating panitumumab
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) 0-1
- ≥18 years of age
Show all 16Show fewer
- Adequate organ function
- neutrophil count (ANC or AGC) ≥1.5 x 109/L
- Platelet count ≥75 x 109/L
- Hemoglobin ≥9.0 g/dL
- Creatinine ≤1.5x upper limit of normal (ULN)
- Hepatic enzymes (AST, ALT)≤2.5x ULN, Total Bilirubin <1.5x ULN
- Magnesium ≥ Lower limit of Normal (LLN)
- Negative serum pregnancy test ≤7 days before starting panitumumab (for women of childbearing potential only)
- Competent to comprehend, sign, and date a written informed consent form
- Sexually active males \& females of reproductive potential must agree to use adequate method of contraception during treatment \& for 6 months after study drug stopped
Who cannot join
- History of other malignancy within past 2 years, except:
- Malignancy treated with curative intent and with no known active disease
- Adequately treated non-melanomatous skin cancer or lentigo maligna with no evidence of disease
- Adequately treated cervical carcinoma in situ with no evidence of disease
- Prostatic intraepithelial neoplasia with no evidence of prostate cancer
- Primary tumor of the nasopharynx (nasopharyngeal cancer), sinuses, salivary gland, or skin. (Squamous cell carcinoma arising in/near nasopharynx is eligible)
Show all 23Show fewer
- Prior radiotherapy in planned field if it prevents standard radiotherapy dose and field
- Prior radiation for head \& neck cancer
- Prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib)
- Prior anti-cancer treatment with: chemotherapy, hormonal therapy, immunotherapy, experimental or approved proteins/antibodies within the past 5 years.
- Prior systemic chemotherapy for study cancer
- Investigational agent or therapy ≤30 days before enrollment and/or have not recovered from such side effects
- Continued chronic use of immunosuppressive agents during the clinical trial period (e.g., methotrexate and cyclosporine), corticosteroids are allowed
- Clinically significant cardiovascular disease (including myocardial infarction (MI), unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤6 months before enrollment
- History of interstitial lung disease e.g., pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. Patients with CT scan findings consistent with lung scarring from chronic obstructive pulmonary disease (COPD) or previous infection are eligible
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results
- Unwilling or unable to comply with study requirements
- Pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- Known positive test(s) for HIV infection
- Major surgery within 2 weeks of enrollment. Staging endoscopy with biopsy/tonsillectomy for head \& neck cancer, tracheostomy, and/or gastrostomy tube placement eligible one day after procedure. May consent to tissue collection biopsy pre-endoscopy/minor surgery and then begin protocol therapy one day after procedure.
- Known allergy/hypersensitivity to any component of the study treatment(s)
- Infection requiring intravenous antibiotics for any uncontrolled infection ≤14 days prior to enrollment
- Subjects on anticoagulant therapy. Aspirin and other anti-platelet agents will not be defined as anticoagulant therapy for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Identification of a Gene Expression Signature Profile for Panitumumab Sensitivity in Untreated Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
The purpose of this study was to identify which cancer-related genes are turned on or turned off in order to determine how well a patient will respond to the study drug, panitumumab. Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects that receive surgery followed by therapy and subjects that receive radiation therapy without surgery.
Subjects entering this study had locally advanced disease that can be treated with surgery and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of consent, a biopsy was required to participate in this trial.
Read the detailed description
The trial was initiated to identify a gene expression signature profile biomarker for panitumumab sensitivity in locally advanced, untreated SCCHN. SCCHN expresses or over expresses EGFR in >90% of tumors. Panitumumab is a fully human IgG2 monoclonal antibody approved for the treatment of epidermal growth factor receptor (EGFR) expressing previously treated metastatic colorectal cancer. It competes with endogenous ligands such as epidermal growth factor and tumor growth factor-α and blocks stimulation of the EGFR. Preclinical experiments have shown that panitumumab has both direct anti-tumor activity and can activate a cellular immune response to SCCHN.This study provides the opportunity to better define the population of patients that would benefit from EGFR inhibition in SCCHN.
Patients received single agent panitumumab in a "window of opportunity" design prior to definitive surgical or radiation therapy. The decision to treat primarily with either surgery or Radiation Therapy (RT) based therapy was based on best medical practice by the treating physician per National Comprehensive Cancer Network (NCCN) guidelines at www.nccn.org.
Response to panitumumab monotherapy before surgery or radiation was evaluated as a continuous variable, and a median split of patients will be used to develop a signature of drug responsiveness. An Affymetrix chip based gene signature model was then developed by analyzing gene expression in panitumumab sensitive versus resistant tumors. Identification of a gene expression profile for tumor sensitivity allowed for prospective trials treating patient populations enriched for likelihood of clinical benefit from panitumumab therapy. It is also possible that a gene signature profile for panitumumab responsiveness identified in SCCHN could be used as a biomarker in other epithelial cancers.
Tumor response as measured by percentage decrease in PET scan standardized uptake value (SUV) level or objective evidence of tumor response (by CT scan or direct measurement) was the basis for examining the activity of panitumumab by means of identifying a gene expression signature that predicted response in this patient population. Therefore, PET scan SUV levels was assessed at baseline prior to any treatment. If a baseline PET/CT was obtained and a lesion identified with SUV level ≥6, an additional pre-treatment research PET/CT was performed after consent (prior to dose #1 panitumumab. A second research PET/CT was also obtained after the first dose of panitumumab as part of this research study. If no baseline PET/CT had been obtained, a research PET was obtained pre-treatment; if SUV level ≥6 an additional research PET was obtained after the first dose of panitumumab.
All subjects underwent imaging, biopsy and a single dose of panitumumab 9mg/kg IV. Two to three weeks after panitumumab, imaging was repeated and a second biopsy was obtained (at surgery for surgery patients) and an optional biopsy for patients receiving RT. Subjects received 2 additional doses of panitumumab during their standard therapy.
- Being tested
- Panitumumab, Surgery, Radiation Therapy
- Keywords
- SCCHN, untreated, Stage III or IVa-b (M0)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix®, ABX-EGF
Single dose Panitumumab 9mg/kg IV (in the vein) prior to definitive therapy (surgery or radiation therapy). Two additional doses of panitumumab 9mg/kg IV may be given at weeks 1 \& 4 of RT alone or weeks 1 \& 4 of cisplatin/RT if they tolerated first dose of panitumumab.
SurgeryProcedure or surgery
Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site).
Radiation TherapyProcedure or surgery
Also called RT
Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration Receives: Drug: Panitumumab; Procedure: Surgery; Procedure: Radiation Therapy |
| Radiation Therapy | Active comparator | Patients who underwent radiation therapy only, in conjunction with panitumumab therapy. Receives: Drug: Panitumumab; Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy
The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria "changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined" in the same manner as in RECIST 1.1.
No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants.
Measured: Baseline to 2 years
Secondary outcomes (2)
Nine (9) Month Progression Free Survival (PFS)
Nine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression).
Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive.
Measured: 9 months
Nine (9) Month Overall Survival (OS)
Overall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMay 2012
Why it stopped: This study was terminated for low accrual.
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 Squamous Cell Carcinoma of the Head and NeckStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neal Ready
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Neal Ready, Duke University
- Investigators
- Neal Ready, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305772
- Sponsor's protocol ID
- Pro00023859
- Other IDs
- 20080645
- Acronym
- TOP0901
- Status last verified
- Aug 2014
- First submitted
- 14 Feb 2011
- Last updated
- 29 Aug 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 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Gene Expression Signature Profile for Panitumumab Sensitivity in Untreated Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT01305772
- Acronym / sponsor ID
- TOP0901 / Pro00023859
- Keywords
- SCCHN, untreated, Stage III or IVa-b (M0)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated for low accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Neal ReadyUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Posted 29 Aug 2014
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 was to identify which cancer-related genes are turned on or turned off in order to determine how well a patient will respond to the study drug, panitumumab. Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects that receive surgery followed by therapy and subjects that receive radiation therapy without surgery.
Subjects entering this study had locally advanced disease that can be treated with surgery and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of consent, a biopsy was required to participate in this trial.
Detailed description
The trial was initiated to identify a gene expression signature profile biomarker for panitumumab sensitivity in locally advanced, untreated SCCHN. SCCHN expresses or over expresses EGFR in >90% of tumors. Panitumumab is a fully human IgG2 monoclonal antibody approved for the treatment of epidermal growth factor receptor (EGFR) expressing previously treated metastatic colorectal cancer. It competes with endogenous ligands such as epidermal growth factor and tumor growth factor-α and blocks stimulation of the EGFR. Preclinical experiments have shown that panitumumab has both direct anti-tumor activity and can activate a cellular immune response to SCCHN.This study provides the opportunity to better define the population of patients that would benefit from EGFR inhibition in SCCHN.
Patients received single agent panitumumab in a "window of opportunity" design prior to definitive surgical or radiation therapy. The decision to treat primarily with either surgery or Radiation Therapy (RT) based therapy was based on best medical practice by the treating physician per National Comprehensive Cancer Network (NCCN) guidelines at www.nccn.org.
Response to panitumumab monotherapy before surgery or radiation was evaluated as a continuous variable, and a median split of patients will be used to develop a signature of drug responsiveness. An Affymetrix chip based gene signature model was then developed by analyzing gene expression in panitumumab sensitive versus resistant tumors. Identification of a gene expression profile for tumor sensitivity allowed for prospective trials treating patient populations enriched for likelihood of clinical benefit from panitumumab therapy. It is also possible that a gene signature profile for panitumumab responsiveness identified in SCCHN could be used as a biomarker in other epithelial cancers.
Tumor response as measured by percentage decrease in PET scan standardized uptake value (SUV) level or objective evidence of tumor response (by CT scan or direct measurement) was the basis for examining the activity of panitumumab by means of identifying a gene expression signature that predicted response in this patient population. Therefore, PET scan SUV levels was assessed at baseline prior to any treatment. If a baseline PET/CT was obtained and a lesion identified with SUV level ≥6, an additional pre-treatment research PET/CT was performed after consent (prior to dose #1 panitumumab. A second research PET/CT was also obtained after the first dose of panitumumab as part of this research study. If no baseline PET/CT had been obtained, a research PET was obtained pre-treatment; if SUV level ≥6 an additional research PET was obtained after the first dose of panitumumab.
All subjects underwent imaging, biopsy and a single dose of panitumumab 9mg/kg IV. Two to three weeks after panitumumab, imaging was repeated and a second biopsy was obtained (at surgery for surgery patients) and an optional biopsy for patients receiving RT. Subjects received 2 additional doses of panitumumab during their standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Drug: Panitumumab, Procedure: Surgery, Procedure: Radiation TherapyPatients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration |
| Radiation Therapy | Active comparator | Drug: Panitumumab, Procedure: Radiation TherapyPatients who underwent radiation therapy only, in conjunction with panitumumab therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Untreated, suspected or histologically documented locally advanced clinical stage III or IVa-b(M0)SCCHN, no evidence of distant metastases. Prior surgery with diagnosis of SCCHN acceptable
- Candidate for definitive surgery or radiation based therapy.
- Fresh frozen tumor tissue must be available for genomic analysis and must pass RNA Quality Control prior to research PET/CT #1 and/or initiating panitumumab
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) 0-1
Key exclusion criteria (23 listed)
- History of other malignancy within past 2 years, except:
- Primary tumor of the nasopharynx (nasopharyngeal cancer), sinuses, salivary gland, or skin. (Squamous cell carcinoma arising in/near nasopharynx is eligible)
- Prior radiotherapy in planned field if it prevents standard radiotherapy dose and field
- Prior radiation for head \& neck cancer
- Prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib)
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: Vectibix®, ABX-EGFSingle dose Panitumumab 9mg/kg IV (in the vein) prior to definitive therapy (surgery or radiation therapy). Two additional doses of panitumumab 9mg/kg IV may be given at weeks 1 \& 4 of RT alone or weeks 1 \& 4 of cisplatin/RT if they tolerated first dose of panitumumab. | Drug | Radiation Therapy, Surgery |
| SurgerySecond biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site). | Procedure or surgery | Surgery |
| Radiation TherapyAlso: RTRadiation therapy was initiated within 8 weeks after surgery, or as soon as possible. | Procedure or surgery | Radiation Therapy, Surgery |
Primary outcome
Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy
Time frame: Baseline to 2 years
The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria "changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined" in the same manner as in RECIST 1.1. No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants.
2 secondary outcomes
Nine (9) Month Progression Free Survival (PFS)
Time frame: 9 months
Nine (9) Month Overall Survival (OS)
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.
Neal Ready, MD, PhD principal investigator
Duke University
2 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 Panitumumab, Surgery and Radiation Therapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Neal Ready at 2 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 16 inclusion and 23 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 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 29 Aug 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?
Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy (time frame: Baseline to 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 29 Aug 2014.