Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Hea… (NCT01313390) | Clinical Trial Compass
TerminatedPhase 1/2
Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer
Stopped: Lack of recruitment
United Kingdom4 participantsStarted 2009-06
Plain-language summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving everolimus together with docetaxel is more effective than giving docetaxel alone in treating patients with head and neck cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus given together with docetaxel in treating patients with recurrent, locally advanced, or metastatic head and neck cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Locally advanced or metastatic disease
* No patients with locally advanced disease for whom radiotherapy is indicated
* Recurrent disease
* Incurable disease
* Measurable disease by RECIST criteria
* Recurrent disease within a prior radiation field can be considered to be measurable
* Patients may have received 1 line of prior chemotherapy (but not a taxane) for locally advanced or metastatic disease
* Patients may have received prior radiation therapy for locally advanced or metastatic disease (but must have completed the radiotherapy \> 6 months before recruitment)
* No disease relapsed within 6 months of radiotherapy
* No evidence of central nervous system metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL
* Urea and creatinine normal
* Serum bilirubin normal
* AST or ALT ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 times ULN
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months (female) or 2 months (male) after the last dose of the study treatment
* No uncontrolled infection
* No mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
* No prior malignancy like…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum-tolerated dose and recommended phase II dose of everolimus in combination with docetaxel (phase I)
2
Safety and tolerability of the combination of everolimus and docetaxel