New combo therapy targets tough head and neck cancers
NCT ID NCT00304278
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tested a combination of the drug Tarceva (erlotinib) with RADPLAT (radiation and intra-arterial cisplatin) in 21 patients with advanced head and neck cancer. The goal was to see if the combination was safe and effective at shrinking tumors. Researchers measured complete and partial responses, as well as overall and disease-free survival.
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) and Cisplatin with Radiation Therapy
- What this could lead to
- If successful, this combination could offer a new treatment option for locally advanced head and neck cancer, potentially improving tumor response and survival.
- What could go wrong
- This is a small, early-phase study (21 participants) with no control group, so results may not be generalizable. Side effects from chemotherapy and radiation can 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Start date
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Mar 2006
- Finished
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Dec 2015
- 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.
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 must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx. * No previous radiation therapy or chemotherapy. * No evidence of distant metastatic disease. * Age \> 18. * Karnofsky performance status of \> 60 (ECOG 2). * ANC \> 1000, platelets \> 100,000, calculated or 24-hour creatinine clearance \> 60. * Study-specific informed consent form. * Protocol treatment must begin \< 8 weeks of diagnostic biopsy. * Ability to understand and the willingness to sign a written informed consent document. * Patients with surgically cured secondary malignancy who have been disease free \> 5 years are eligible. Exclusion Criteria: * Radiologic evidence of bone destruction. * Previous or concurrent head and neck primaries. * Prior surgery to study site other than biopsy. * Patients receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).
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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
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Simmons Cooper Cancer Institute/SIU School of Medicine
Springfield, Illinois, 62702, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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