Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Everolimus Versus Placebo in Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Chicago
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: April 23, 2010
Last updated: October 14, 2014
Last verified: October 2014

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

Condition Intervention Phase
Head and Neck Cancer
Drug: Everolimus (RAD 001) or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 2 year Tumor Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Subjects will be treated for a maximum of 1 year and followed for progression (tumor growth) or 2 years (whichever comes first).

Estimated Enrollment: 160
Study Start Date: April 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus (RAD001) or Placebo
Subjects will receive Everolimus or Placebo.
Drug: Everolimus (RAD 001) or placebo
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01111058

Contact: Dale Rush 773-834-7424

United States, Florida
University of Miami Active, not recruiting
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Kevin Puyleart   
Principal Investigator: Mark Agulnik, MD         
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Dale Rush    773-834-7424   
Principal Investigator: Ezra E. Cohen, M.D.         
University of Illinois-Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Jennifer Collier   
Principal Investigator: Lawrence Feldman, MD         
Ingalls Cancer Research Center Recruiting
Harvey, Illinois, United States, 60426
Contact: Amanda Sarsfield   
Principal Investigator: Mark Kozloff, MD         
United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Barb Liles   
Principal Investigator: Prakash Neupane, MD         
United States, Louisiana
Louisianna State University Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Amy Jones   
Principal Investigator: Syed Jafri, M.D.         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Elizabeth A Grimm   
Principal Investigator: Miriam O'Leary, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Suzanne Miesterfeld   
Principal Investigator: Francis Worden, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Patricia Fernandes   
Principal Investigator: Gautam G Jha, MBBS         
United States, Mississippi
University of Mississippi Recruiting
Jackson, Mississippi, United States, 39216
Contact: Elizabeth Tarsi   
Principal Investigator: Karen T Pitman, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Melissa Haley   
Principal Investigator: Douglas Adkins, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Ayoola Aboyade-Cole   
Principal Investigator: Juneko Grilley-Olson, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: William Towler   
Principal Investigator: Maura Gillison, MD         
United States, South Carolina
Medical University of South Carolina Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jessica Hendricks   
Principal Investigator: Keisuke Shirai, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tanya E Davis   
Principal Investigator: Jill Gilbert, MD         
United States, Texas
The University of Texas Medical Branch at Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Lisa Hernandez Garcia   
Principal Investigator: Vicente A Resto, MD         
Sponsors and Collaborators
University of Chicago
Novartis Pharmaceuticals
Principal Investigator: Ezra E. Cohen, M.D. The University of Chicago Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago Identifier: NCT01111058     History of Changes
Other Study ID Numbers: 09-266-B
Study First Received: April 23, 2010
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Squamous Cell Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 03, 2015