Clinical trial · Interventional
Erlotinib and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed by Surgery
CCCWFU 60307 - Pilot Study to Evaluate the Anti-tumor Effect of Erlotnib Administered Befor Surgery in Operable Patients With Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with erlotinib. PURPOSE: This clinical trial is studying how well erlotinib works when given before surgery in treating patients with head and neck cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| liquid chromatography | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Erlotinib
- interventionNames
- Drug: erlotinib hydrochloride
- Genetic: protein analysis
- Genetic: western blotting
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: liquid chromatography
- Other: mass spectrometry
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Identify tissue biomarkers of EGFR activation and inhibition for which initial values and changes after treatment with erlotinib hydrochloride would best correlate with the objective response of the tumor measured clinically and radiologically
Secondary outcomes (6)
- measure
- Objective response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx * SCC of the base of the tongue, pharynx, larynx, or hypopharynx are eligible provided additional biopsy tissue has been already saved in the Tumor Tissue Core Laboratory for research purposes * SCC of the oral cavity or tonsils are eligible only if they already have or agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies * Candidate for surgical treatment with an established date for surgery with ≥ a 15 day window of opportunity * Measurable disease by CT scan or MRI * No nasopharyngeal carcinoma PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * ANC \> 1,500/µL * Platelet count \> 100,000/µL * Total bilirubin \< 1.5 mg/dL * AST/ALT \< 2 times upper limit of normal * Creatinine \< 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements * Significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, or myocardial infarction within the past 3 months) * Uncontrolled congestive heart failure * Cardiomyopathy with decreased ejection fraction * History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on chest CT scan * Clinically significant ophthalmologic abnormalities * HIV positivity PRIOR CONCURRENT THERAPY: * More than 1 year since prior chemotherapy, biologic therapy, or hormonal therapy * No prior radiotherapy or chemotherapy for this tumor * No prior EGFR inhibitors * No concurrent grapefruit or grapefruit juice * No other concurrent investigational agents
References
Publications (1)
- DERIVEDPorosnicu M, O'Brien Cox A, Waltonen JD, Bunch PM, D'Agostino R, Lycan TW, Taylor R, Williams DW 3rd, Chen X, Shukla K, Kouri BE, Walker T, Kucera G, Patwa HS, Sullivan CA, Browne JD, Furdui CM. Early [18]FDG PET/CT scan predicts tumor response in head and neck squamous cell cancer patients treated with erlotinib adjusted per smoking status. Front Oncol. 2022 Aug 30;12:939118. doi: 10.3389/fonc.2022.939118. eCollection 2022. PMID 36110959