Can a daily pill shut down head and neck tumors before surgery?
NCT ID NCT00144976
First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time
Summary
Researchers are testing whether erlotinib, a drug that blocks a cancer growth signal, changes head and neck squamous cell tumors when taken before surgery. Participants take a 150 mg pill once a day for 18 to 28 days, then have their planned operation. The study measures whether the drug shuts down the EGFR protein in the tumors and compares drug levels in the blood with the effect on the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- erlotinib, a drug that blocks a cancer growth signal
- What this could lead to
- If erlotinib blocks the tumor's growth signal as intended, doctors could use it before surgery to help control head and neck cancers.
- What could go wrong
- This is a small pilot study with 43 people, so any signal may not hold up in larger trials. Erlotinib can cause rash, diarrhea, and other side effects, and it may not affect these tumors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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43 people
The number who actually took part.
- Start date
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Oct 2003
- Finished
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Dec 2006
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Neck and head epidermoid carcinoma histologically proved. Patient with an ENT epidermoid tumor can be included in the study if this relapse is located in an area not irradiated yet. * At least tumor classified T2NXM0 * Patient who can be picked up in a first surgery with a curative purpose or who must have a necessity's surgery (cervical curettage for voluminous adenopathies before radiotherapy) * Patient without clinical or radiological sign of metastatic disease * Good general status (OMS ≤ 2) * Patient able to ingest food. * Age ≥ 18 years * Well-informed written consent, signed by the patient. * Patient with sickness benefit Exclusion Criteria: * Patient with relapse ever treated by radiotherapy * Other prospective study's participation * Recent and massive digestive haemorrhage * Medical contra-indication like main general status alteration, uncontrolled serious infectious disease, main uncontrolled metabolic anomaly ongoing. * Pre-existent pulmonary pathology (BPCO, pleurisy, lymphangitis, interstitial syndrome) * Severe cardiac pathology (stage 3 or 4 cardiac insufficiency, unstable angina pectoris, uncontrolled arrhythmia, myocardium's infarction antecedent during the year that precede the inclusion. * Ophthalmic pathology antecedent concerning the ocular surface or lens-carrier * Concomitant administration, by local or general tract, of drug responsible for ocular drought or which could delay the epithelial cicatrization * Less than 1000 polynuclear neutrophil leucocytes or less than 75000 blood-platelets at inclusion * Bilirubin at higher concentration than one point five times the normal * Renal insufficiency (glomerular filtration flow ≤ 40 ml/min)calculated in accordance with Cockroft's formula * Tacking of Beta blockers, amiodarone, NSAIDs, bleomycin, just before or during the study * Pregnant or nursing women * Patient under guardianship or trusteeship.
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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
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Center Oscar Lambret
Lille, France
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Institut claudius regaud
Toulouse, France
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Other studies related to the condition(s) this trial covers.
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