Clinical trial NCT01111058: Everolimus Versus Placebo in Head and Neck Cancer
Official title: Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Squamous Cell Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2010-04-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 2 Year Progression Free Survival Rate
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With Toxicity
timeFrame: 4 years
measure: Site of Progression: Local-regional
timeFrame: 4 years
measure: Site of Progression: Distant
timeFrame: 4 years
measure: Site of Progression: Unknown
timeFrame: 4 years
measure: Second Primary Tumor
timeFrame: 4 years
measure: Akt/mTOR Pathway Activation
timeFrame: Baseline
measure: Correlation of Akt/mTOR Status With Progression-free Survival
timeFrame: 4 years
measure: Determine if PTEN Status is a Predictive Biomarker
timeFrame: 4 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois-Chicago
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Shreveport
country: United States
facility: Louisianna State University
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: The University of Chicago Medical Center
name: Tanguy Seiwert, M.D.
role: PRINCIPAL_INVESTIGATOR
References: