Could a cancer pill before surgery help head and neck patients?
NCT ID NCT00954226
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested two doses of the drug erlotinib (Tarceva) given before surgery in 48 people with head and neck cancer. The goal was to see how the drug affects a protein called phospho-Akt in tumor samples. Researchers hope erlotinib might slow tumor growth by blocking certain enzymes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- erlotinib hydrochloride (Tarceva)
- What this could lead to
- If it works, this could point toward a way to shrink tumors before surgery, potentially improving outcomes for head and neck cancer patients.
- What could go wrong
- This is a very early phase 1 trial with only 48 participants, so results may not apply broadly. The drug may not show meaningful benefit or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
48 people
The number who actually took part.
- Started
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Aug 2009
- Finished
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Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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