Everolimus Versus Placebo in Head and Neck Cancer

Phase 2

Terminated

Brief Summary: Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
18 years or older.
Performance status 70% or better.
Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent.

Exclusion Criteria

Currently receiving anti-cancer treatment.
Major surgery or traumatic injury within 4 weeks.
Radiotherapy related toxicities.
Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
Receiving other investigational drugs.
Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
Show evidence of disease (cancer).
Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
Active, uncontrolled severe infections
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
Known History of HIV positivity.
Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
Patients with an active, bleeding diathesis.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.

contraception, during the study and for 8 weeks after the end of treatment

Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
History of noncompliance to medical regimens.
Patients unwilling to or unable to comply with the protocol.

Arm && Interventions

Group	Intervention	Description
Everolimus (RAD001)	Everolimus (RAD 001)	Subjects will receive Everolimus 10 mg daily
Placebo	Placebo	Subjects will receive double-blind placebo

Primary Outcome Measures

Name	Time	Method
2 Year Progression Free Survival Rate	2 years	Time to disease progression or death from any cause--2 year rate

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Toxicity	4 years	Adverse event rate, any type, any grade regardless of attribution
Site of Progression: Local-regional	4 years	Number of patients with local-regional progression
Site of Progression: Distant	4 years	Number of patients with distant progression
Second Primary Tumor	4 years	Number of patients with second primary tumor
Correlation of Akt/mTOR Status With Progression-free Survival	4 years	mTOR positive in tumor tissue
Site of Progression: Unknown	4 years	Number of patients with unknown site of progression
Akt/mTOR Pathway Activation	Baseline	mTOR positive in tumor tissue
Determine if PTEN Status is a Predictive Biomarker	4 years	Differential effect of PTEN status on progression-free survival between the two arms

Locations (17): Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Miami
🇺🇸
Miami, Florida, United States
University of Illinois-Chicago
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Chicago, Illinois, United States
The University of Chicago Medical Center
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Chicago, Illinois, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Tufts Medical Center
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Boston, Massachusetts, United States
Ingalls Cancer Research Center
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Harvey, Illinois, United States
Washington University
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Saint Louis, Missouri, United States
Louisianna State University
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Shreveport, Louisiana, United States
University of Michigan
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Ann Arbor, Michigan, United States
University of Kansas
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Kansas City, Kansas, United States
Ohio State University
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Columbus, Ohio, United States
The University of Texas Medical Branch at Galveston
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Galveston, Texas, United States
Medical University of South Carolina Hollings Cancer Center
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Charleston, South Carolina, United States
Vanderbilt University
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Nashville, Tennessee, United States
University of Mississippi
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Jackson, Mississippi, United States
University of North Carolina
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Chapel Hill, North Carolina, United States