Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Docetaxel; Everolimus; Sirolimus

Criteria

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 likely to interfere with the patient's ability to comply with treatment and/or follow up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy for any cancer, except for head and neck cancer

• No prior taxane

• No prior therapy with any erbB inhibitors (except cetuximab given with radiotherapy, as indicated in treatment algorithm)

• More than 6 months since prior radiotherapy for locally advanced or metastatic disease

• At least 4 weeks since prior investigational drug

• No concurrent use of drugs known to inhibit CYP3A4 (except dexamethasone), or block P-glycoprotein, including grapefruit juice

• No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or experimental medications

• No concurrent live vaccines during everolimus therapy