Everolimus Versus Placebo in Head and Neck Cancer

March 25, 2020 updated by: University of Chicago

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.

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois-Chicago
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Research Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • Louisianna State University
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch at Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus (RAD001)
Subjects will receive Everolimus 10 mg daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 Year Progression Free Survival Rate
Time Frame: 2 years
Time to disease progression or death from any cause--2 year rate
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Toxicity
Time Frame: 4 years
Adverse event rate, any type, any grade regardless of attribution
4 years
Site of Progression: Local-regional
Time Frame: 4 years
Number of patients with local-regional progression
4 years
Site of Progression: Distant
Time Frame: 4 years
Number of patients with distant progression
4 years
Site of Progression: Unknown
Time Frame: 4 years
Number of patients with unknown site of progression
4 years
Second Primary Tumor
Time Frame: 4 years
Number of patients with second primary tumor
4 years
Akt/mTOR Pathway Activation
Time Frame: Baseline
mTOR positive in tumor tissue
Baseline
Correlation of Akt/mTOR Status With Progression-free Survival
Time Frame: 4 years
mTOR positive in tumor tissue
4 years
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Tanguy Seiwert, M.D., The University of Chicago Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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