- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111058
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
Conditions
Intervention / Treatment
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
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
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Chicago, Illinois, United States, 60612
- University of Illinois-Chicago
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Harvey, Illinois, United States, 60426
- Ingalls Cancer Research Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas
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Louisiana
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Shreveport, Louisiana, United States, 71130
- Louisianna State University
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina Hollings Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Texas
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Galveston, Texas, United States, 77555
- The University of Texas Medical Branch at Galveston
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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
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10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
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Experimental: Placebo
Subjects will receive double-blind placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2 Year Progression Free Survival Rate
Time Frame: 2 years
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Time to disease progression or death from any cause--2 year rate
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Toxicity
Time Frame: 4 years
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Adverse event rate, any type, any grade regardless of attribution
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4 years
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Site of Progression: Local-regional
Time Frame: 4 years
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Number of patients with local-regional progression
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4 years
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Site of Progression: Distant
Time Frame: 4 years
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Number of patients with distant progression
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4 years
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Site of Progression: Unknown
Time Frame: 4 years
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Number of patients with unknown site of progression
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4 years
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Second Primary Tumor
Time Frame: 4 years
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Number of patients with second primary tumor
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4 years
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Akt/mTOR Pathway Activation
Time Frame: Baseline
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mTOR positive in tumor tissue
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Baseline
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Correlation of Akt/mTOR Status With Progression-free Survival
Time Frame: 4 years
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mTOR positive in tumor tissue
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4 years
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Determine if PTEN Status is a Predictive Biomarker
Time Frame: 4 years
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Differential effect of PTEN status on progression-free survival between the two arms
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4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-266-B
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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