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Everolimus Versus Placebo in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111058
Recruitment Status : Terminated (Slow accrual)
First Posted : April 27, 2010
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Novartis Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Everolimus (RAD 001) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : April 2010
Actual Primary Completion Date : April 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: Everolimus (RAD001)
Subjects will receive Everolimus 10 mg daily
Drug: Everolimus (RAD 001)
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).

Experimental: Placebo
Subjects will receive double-blind placebo
Other: Placebo

Primary Outcome Measures :
  1. 2 Year Progression Free Survival Rate [ Time Frame: 2 years ]
    Time to disease progression or death from any cause--2 year rate

Secondary Outcome Measures :
  1. Number of Participants With Toxicity [ Time Frame: 4 years ]
    Adverse event rate, any type, any grade regardless of attribution

  2. Site of Progression: Local-regional [ Time Frame: 4 years ]
    Number of patients with local-regional progression

  3. Site of Progression: Distant [ Time Frame: 4 years ]
    Number of patients with distant progression

  4. Site of Progression: Unknown [ Time Frame: 4 years ]
    Number of patients with unknown site of progression

  5. Second Primary Tumor [ Time Frame: 4 years ]
    Number of patients with second primary tumor

  6. Akt/mTOR Pathway Activation [ Time Frame: Baseline ]
    mTOR positive in tumor tissue

  7. Correlation of Akt/mTOR Status With Progression-free Survival [ Time Frame: 4 years ]
    mTOR positive in tumor tissue

  8. Determine if PTEN Status is a Predictive Biomarker [ Time Frame: 4 years ]
    Differential effect of PTEN status on progression-free survival between the two arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111058

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Sponsors and Collaborators
University of Chicago
Novartis Pharmaceuticals
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Principal Investigator: Tanguy Seiwert, M.D. The University of Chicago Medical Center
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Additional Information:
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Responsible Party: University of Chicago Identifier: NCT01111058    
Other Study ID Numbers: 09-266-B
First Posted: April 27, 2010    Key Record Dates
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020
Last Verified: March 2020
Keywords provided by University of Chicago:
Squamous Cell Cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs