Head and neck cancer trial pulled before it began
NCT ID NCT01326468
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study aimed to test the safety of adding the drug Temsirolimus (Torisel) to standard chemoradiotherapy for people with advanced head and neck cancer. The goal was to find a safe dose of Temsirolimus when given alongside radiation and other chemotherapy drugs like Cetuximab (Erbitux). However, the study was withdrawn before any participants were enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Temsirolimus (Torisel) and Cetuximab (Erbitux)
- What this could lead to
- If it had worked, this could have pointed toward a more effective treatment for advanced head and neck cancer by adding Temsirolimus to standard therapy.
- What could go wrong
- The trial was withdrawn before any patients were enrolled, so no results are available. It is unknown whether the combination would have been safe or effective.
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
-
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.
- Started
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Dec 2011
- Expected to finish
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Dec 2016
An estimate. End dates often move.
- 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: Cohort A: * Stage III or IVA-B HNC without prior RT except non-sm0kers with human papillomavirus (HPV) + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible. * Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B * Age \> or = 18 * Karnofsky performance status \> 70 * No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable). * Adequate renal function (creatinine \< 1.5 mg/dl), based upon blood work performed within 1 month prior to registration. * Adequate hepatic function (alkaline phosphatase and AST/ALT \< 2 x ULN) based upon bloodwork performed within 1 month prior to registration. * Adequate bone marrow function (ANC \> 1.5; platelets \> 100K) based upon blood work performed within one month prior to registration. * Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF). * No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy. Cohort B: * Platinum ineligible patients as defined by the multidisciplinary team. * Stage III or IVA-B HNC without prior RT except nonsmokers with HPV + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible. * Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B * Age \> or = 18 * KPS \> 70 * No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable). * Adequate hepatic function (alkaline phosphatase and AST/ALT \< 2 x ULN) based upon bloodwork performed within 1 month prior to registration. * Adequate bone marrow function (ANC \> 1.5; platelets \> 100K) based upon bloodwork performed within one month prior to registration. * Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF). * No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy. Exclusion Criteria: * Current, recent (within 4 weeks of enrollment in this study) or planned participation in an experimental drug study other than this one. * KPS \< 70% * Expected survival \< 6 months * Early stage head and neck cancer as defined as T1N0 or T2N0 by AJCC 7th edition * Poorly controlled blood pressure, defined as systolic bp \> 150 and/or diastolic bp \> 100 despite medication. * Unstable angina. * NY Heart Association (NYHA) Grade II or greater congestive heart failure. * History of myocardial infarction or stroke within 6 months. * Clinically significant peripheral vascular disease. * Evidence of bleeding diathesis or coagulopathy. * Presence of brain or spinal cord metastases. * Major surgical procedure(s), open biopsy or significant traumatic injury within 14 days prior to initiation of radiation therapy and/or anticipation of need for major surgical procedure during the course of the study. * Minor surgical procedures such as needle/core biopsies, dental work, PEG placement, tracheostomy within 10 days prior to initiation of radiation therapy. * Carotid artery exposure or other signs of impending carotid artery hemorrhage. * History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment. * Serious, non-healing wound, ulcer, or bone fracture. * Prior irradiation that would result in radiotherapy field "overlap." * Requirement for high dose oral anticoagulation (i.e., goal INR \> 2.0). "Mini-dose" anticoagulation may be used to assist in patency of central venous lines. Subcutaneous low-molecular weight heparin is allowable. * No known allergies to any of the drug therapies being used in this protocol. * No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
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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.
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Other studies related to the condition(s) this trial covers.
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