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Head and neck cancer trial pulled before it began

NCT ID NCT01326468

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 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 However, the study was withdrawn before any participants were enrolled, so no data was collected.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The trial was withdrawn before any patients were enrolled, so no results are available.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

Dec 2011

Expected to finish

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

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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