Could a lung cancer drug boost chemo for head and neck tumors?
NCT ID NCT01927744
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tested whether adding the drug erlotinib to standard chemotherapy (docetaxel plus cisplatin or carboplatin) helps shrink head and neck tumors before surgery. 55 patients with advanced but operable head and neck cancer took part. The main goal was to see how many had a major response in the tumor after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- erlotinib (Tarceva) plus docetaxel and cisplatin or carboplatin
- What this could lead to
- If it works, adding erlotinib to standard chemo could shrink head and neck tumors more before surgery, potentially improving outcomes.
- What could go wrong
- This is a small, early-phase trial with only 55 participants. The benefit of erlotinib is unproven for this cancer, and side effects from the drug combination may be significant.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
55 people
The number who actually took part.
- Started
-
Dec 2013
- Finished
-
Jan 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
-
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: 1. Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study. 2. Patients must have surgically resectable disease, in the opinion of the treating physician 3. Age ≥ 18 years. 4. ECOG PS ≤ 2 (Appendix C) 5. Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L; 7\. Platelet count ≥ 100 x 109/L; 8\. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN); 9\. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is \> ULN); 10\. Alkaline phosphatase ≤ 2.5 x ULN; 11\. Serum creatinine ≤ 1.5 x ULN. 12\. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation. 13\. Written informed consent to participate in the study according to the investigational review board (IRB). Exclusion criteria: 1. Histology other than squamous cell carcinoma. 2. Primary sites other than oral cavity. 3. Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed 4. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted 5. Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma. 6. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician. 7. History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80. 8. Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer. 9. Women who are pregnant or breast-feeding and women or men not practicing effective birth control.
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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
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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