Everolimus Versus Placebo in Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Chicago
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01111058
First received: April 23, 2010
Last updated: January 23, 2014
Last verified: January 2014

April 23, 2010
January 23, 2014
April 2010
December 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01111058 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Everolimus Versus Placebo in Head and Neck Cancer
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Head and Neck Cancer
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).
Experimental: Everolimus (RAD001) or Placebo
Subjects will receive Everolimus or Placebo.
Intervention: Drug: Everolimus (RAD 001) or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
June 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Dale Rush 773-834-7424 drush@medicine.bsd.uchicago.edu
United States
 
NCT01111058
09-266-B
No
University of Chicago
University of Chicago
Novartis Pharmaceuticals
Principal Investigator: Ezra E. Cohen, M.D. The University of Chicago Medical Center
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP