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Could a lung cancer drug boost chemo for head and neck tumors?

NCT ID NCT01927744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.