Everolimus Versus Placebo in Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: Everolimus (RAD 001)Other: Placebo
- Registration Number
- NCT01111058
- Lead Sponsor
- University of Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (17)
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Illinois-Chicago
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Ingalls Cancer Research Center
🇺🇸Harvey, Illinois, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Louisianna State University
🇺🇸Shreveport, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
Medical University of South Carolina Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States