Recurrent Head and Neck CarcinomaPhase 1NCT00954226
Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
A Phase 1 study testing Erlotinib Hydrochloride and Laboratory Biomarker Analysis in people with Recurrent Head and Neck Carcinoma and Recurrent Salivary Gland Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Carcinoma, Recurrent Salivary Gland Carcinoma, Recurrent Skin Carcinoma
- What is being tested?
- Erlotinib Hydrochloride and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2009to 30 Apr 2025
- Phase
- Phase 1
- 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
- Patients with histologically confirmed cancer of the head and neck. Patients with salivary gland tumors and squamous cell carcinomas of the skin are also eligible. (Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin and determined to be surgically resectable will be considered for eligibility. These patients are typically seen in the Head \& Neck surgery clinic and decisions for study consideration will be based on consultations with the department of Head \& Neck surgery.)
- The patient must have biopsy-accessible disease.
- Patients must be surgical candidates (either definitive or palliative setting).
- Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy.
- Patients must have a performance score (ECOG) of 0-2.
- Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1,000/mm³, and a platelet count of >/= 50,000/mm³.Patients must have adequate liver function with a bilirubin </= 1.5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be </= 2 x the ULN and alkaline phosphatase must be </= 2 x ULN.
Show all 10Show fewer
- Patients should have adequate renal function (serum creatinine </= 1.5 x ULN).
- Age >/= 18 years
- Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.
Who cannot join
- Patients with prior exposure to small molecule tyrosine kinase inhibitors or EGFR-targeted antibodies within the past 6 months.
- Patients for whom, in the opinion of the treating surgeon, the administration of erlotinib would cause a deleterious delay in surgical treatment.
- Patients with uncompensated congestive cardiac failure.
- Patients with an organ allograft.
- Patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could limit compliance with study requirements.
- Female patients who are pregnant or breastfeeding
- Patients currently on chemotherapy, immunotherapy, or therapy with monoclonal antibodies or other investigational agents with anti-tumor activity
Trial locations and contacts
1 site in 1 country.
About this study
This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effects of erlotinib (erlotinib hydrochloride) 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose) on the phosphorylation of AKT protein downstream from epidermal growth factor receptor (EGFR).
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose).
II. To correlate the effects of erlotinib on the phosphorylation of AKT with the immunohistochemical expression level of EGFR and the level of amplification of the EGFR gene as determined by fluorescent in situ hybridization (FISH).
III. To evaluate the preliminary response rate with a short course of erlotinib.
IV. To evaluate changes in the activation status of proteins downstream from EGFR and other receptor tyrosine kinases and in markers of epithelial to mesenchymal transition.
- To evaluate changes in blood-based biomarkers. VI. To evaluate the effects of a higher dose of erlotinib (300 mg/day) in current smokers.
TERTIARY OBJECTIVES:
- To evaluate EGFR gene copy number by fluorescent in situ hybridization. II. To evaluate immunohistochemistry, western blotting and reverse phase protein lysate arrays to assess the activation (usually phosphorylation) status of other downstream proteins from EGFR and other receptor tyrosine kinases (these will include, but are not restricted to: EGFR itself, phosphatidylinositol 3 Kinase [PI3K], AKT, mammalian target of rapamycin [mTOR], glycogen synthase kinase 3 [GSK3], p70 ribosomal S6 kinase [p70S6K], S6, 4E-binding protein 1[4E-BP1], MEK1/2, mitogen-activated protein kinase [MAPK], p38, -c-Jun N-terminal kinase [JNK], insulin-like growth factor 1 receptor [IGF-1R], IGF-2R, mesenchymal epithelial transition [MET], hypoxia-inducible factor [HIF]) both before and after treatment with erlotinib.
III. To evaluate immunohistochemical expression levels of markers of epithelial to mesenchymal transition (these will include, but are not restricted to: e-cadherin and vimentin).
IV. To study blood-based biomarkers of interest, which will include (but are not restricted to): trough levels of erlotinib and its metabolites, a panel of 59 cytokine and angiogenic factors measured by available Luminex multiplex beads kits (Bio-Plex 27-Plex \& 23-Plex Kits [Bio-Rad, Hercules, CA] and Human cardiovascular disease [CVD] Biomarker Panel 1 kit [Linco Research, Inc., St, Charles, MO]) as well as validated enzyme-linked immunosorbent assays for soluble vascular endothelial growth factor receptor 1(VEGFR1), VEGFR2 (Invitrogen, Carlsbad, CA), total IGF-1, IGF-2, insulin-like growth factor-binding protein (IGFBP3) (DSL, Webster, TX), and osteopontin (R\&D Systems, Minneapolis, MN).
- To evaluate whole genome sequencing and/or sequencing of specific genes of interest, analysis of gene copy number, messenger ribonucleic acid (mRNA) expression profiles, non-coding RNA expression profiles, single nucleotide polymorphisms, deoxyribonucleic acid (DNA) methylation profiles, immunohistochemistry of proteins of interest to head and neck cancer biology, and proteomics in tumor tissue and/or normal tissue (including blood) before and after treatment with erlotinib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard-dose erlotinib hydrochloride orally (PO) once daily (QD) for 2-3 weeks (up to 8 weeks if surgery is delayed).
ARM II: Patients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed).
After completion of study treatment, patients are followed up within 30 days.
- Conditions
- Recurrent Head and Neck Carcinoma, Recurrent Salivary Gland Carcinoma, Recurrent Skin Carcinoma, Skin Squamous Cell Carcinoma
- Being tested
- Erlotinib Hydrochloride, Laboratory Biomarker Analysis
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib HydrochlorideDrug
Also called Cp-358,774, OSI-774, Tarceva
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard-dose erlotinib hydrochloride) | Experimental | Patients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed). Receives: Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis |
| Arm II (high-dose erlotinib hydrochloride) | Experimental | Patients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed). Receives: Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modulation of the biomarker phospho-Akt in tumor specimens
Modulation of phospho-Akt (difference in immunohistochemistry [IHC] score between the surgical specimen and the baseline biopsy) will be compared between the two treatment arms (i.e., standard-dose and high-dose) with the use of Wilcoxon rank sum test.
Measured: From baseline to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study start5 Aug 2009
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Xiuning Le, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954226
- Sponsor's protocol ID
- 2008-0137
- Other IDs
- NCI-2012-01639, NCI-2010-01142, 2008-0137
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2009
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00954226
- Acronym / sponsor ID
- 2008-0137
- Conditions
- Recurrent Head and Neck Carcinoma, Recurrent Salivary Gland Carcinoma, Recurrent Skin Carcinoma, Skin Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Aug 2009 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Aug 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 randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effects of erlotinib (erlotinib hydrochloride) 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose) on the phosphorylation of AKT protein downstream from epidermal growth factor receptor (EGFR).
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day (high-dose).
II. To correlate the effects of erlotinib on the phosphorylation of AKT with the immunohistochemical expression level of EGFR and the level of amplification of the EGFR gene as determined by fluorescent in situ hybridization (FISH).
III. To evaluate the preliminary response rate with a short course of erlotinib.
IV. To evaluate changes in the activation status of proteins downstream from EGFR and other receptor tyrosine kinases and in markers of epithelial to mesenchymal transition.
- To evaluate changes in blood-based biomarkers. VI. To evaluate the effects of a higher dose of erlotinib (300 mg/day) in current smokers.
TERTIARY OBJECTIVES:
- To evaluate EGFR gene copy number by fluorescent in situ hybridization. II. To evaluate immunohistochemistry, western blotting and reverse phase protein lysate arrays to assess the activation (usually phosphorylation) status of other downstream proteins from EGFR and other receptor tyrosine kinases (these will include, but are not restricted to: EGFR itself, phosphatidylinositol 3 Kinase [PI3K], AKT, mammalian target of rapamycin [mTOR], glycogen synthase kinase 3 [GSK3], p70 ribosomal S6 kinase [p70S6K], S6, 4E-binding protein 1[4E-BP1], MEK1/2, mitogen-activated protein kinase [MAPK], p38, -c-Jun N-terminal kinase [JNK], insulin-like growth factor 1 receptor [IGF-1R], IGF-2R, mesenchymal epithelial transition [MET], hypoxia-inducible factor [HIF]) both before and after treatment with erlotinib.
III. To evaluate immunohistochemical expression levels of markers of epithelial to mesenchymal transition (these will include, but are not restricted to: e-cadherin and vimentin).
IV. To study blood-based biomarkers of interest, which will include (but are not restricted to): trough levels of erlotinib and its metabolites, a panel of 59 cytokine and angiogenic factors measured by available Luminex multiplex beads kits (Bio-Plex 27-Plex \& 23-Plex Kits [Bio-Rad, Hercules, CA] and Human cardiovascular disease [CVD] Biomarker Panel 1 kit [Linco Research, Inc., St, Charles, MO]) as well as validated enzyme-linked immunosorbent assays for soluble vascular endothelial growth factor receptor 1(VEGFR1), VEGFR2 (Invitrogen, Carlsbad, CA), total IGF-1, IGF-2, insulin-like growth factor-binding protein (IGFBP3) (DSL, Webster, TX), and osteopontin (R\&D Systems, Minneapolis, MN).
- To evaluate whole genome sequencing and/or sequencing of specific genes of interest, analysis of gene copy number, messenger ribonucleic acid (mRNA) expression profiles, non-coding RNA expression profiles, single nucleotide polymorphisms, deoxyribonucleic acid (DNA) methylation profiles, immunohistochemistry of proteins of interest to head and neck cancer biology, and proteomics in tumor tissue and/or normal tissue (including blood) before and after treatment with erlotinib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard-dose erlotinib hydrochloride orally (PO) once daily (QD) for 2-3 weeks (up to 8 weeks if surgery is delayed).
ARM II: Patients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed).
After completion of study treatment, patients are followed up within 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard-dose erlotinib hydrochloride) | Experimental | Drug: Erlotinib Hydrochloride, Other: Laboratory Biomarker AnalysisPatients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed). |
| Arm II (high-dose erlotinib hydrochloride) | Experimental | Drug: Erlotinib Hydrochloride, Other: Laboratory Biomarker AnalysisPatients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed cancer of the head and neck. Patients with salivary gland tumors and squamous cell carcinomas of the skin are also eligible. (Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin and determined to be surgically resectable will be considered for eligibility. These patients are typically seen in the Head \& Neck surgery clinic and decisions for study consideration will be based on consultations with the department of Head \& Neck surgery.)
- The patient must have biopsy-accessible disease.
- Patients must be surgical candidates (either definitive or palliative setting).
- Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy.
- Patients must have a performance score (ECOG) of 0-2.
Key exclusion criteria (7 listed)
- Patients with prior exposure to small molecule tyrosine kinase inhibitors or EGFR-targeted antibodies within the past 6 months.
- Patients for whom, in the opinion of the treating surgeon, the administration of erlotinib would cause a deleterious delay in surgical treatment.
- Patients with uncompensated congestive cardiac failure.
- Patients with an organ allograft.
- Patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could limit compliance with study requirements.
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 |
|---|---|---|
| Erlotinib HydrochlorideAlso: Cp-358,774, OSI-774, TarcevaGiven PO | Drug | Arm I (standard-dose erlotinib hydrochloride), Arm II (high-dose erlotinib hydrochloride) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (standard-dose erlotinib hydrochloride), Arm II (high-dose erlotinib hydrochloride) |
Primary outcome
Change in modulation of the biomarker phospho-Akt in tumor specimens
Time frame: From baseline to surgery
Modulation of phospho-Akt (difference in immunohistochemistry [IHC] score between the surgical specimen and the baseline biopsy) will be compared between the two treatment arms (i.e., standard-dose and high-dose) with the use of Wilcoxon rank sum test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Recurrent Head and Neck Carcinoma
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Head and Neck Cancer, Relapse
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.
Xiuning Le principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erlotinib Hydrochloride and Laboratory Biomarker Analysis in people with Recurrent Head and Neck Carcinoma and Recurrent Salivary Gland Carcinoma, run by M.D. Anderson Cancer Center 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 10 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 modulation of the biomarker phospho-Akt in tumor specimens (time frame: From baseline to surgery). 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 5 Sep 2025.