Head and Neck CancerPhase 2NCT01111058
Everolimus Versus Placebo in Head and Neck Cancer
A Phase 2 study testing Everolimus (RAD 001) in people with Head and Neck Cancer, run by University of Chicago at 17 sites in United States.
Trial summary
Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Everolimus (RAD 001)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2010to Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48109
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Illinois-Chicago
Chicago, Illinois, 60612
The University of Chicago Medical Center
Chicago, Illinois, 60637
Ohio State University
Columbus, Ohio, 43210
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Ingalls Cancer Research Center
Harvey, Illinois, 60426
University of Mississippi
Jackson, Mississippi, 39216
University of Kansas
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Louisianna State University
Shreveport, Louisiana, 71130
Washington University
St Louis, Missouri, 63110
About this study
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)
Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Everolimus (RAD 001), Placebo
- Keywords
- Squamous Cell Cancer
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (RAD 001)Drug
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Everolimus (RAD001) | Experimental | Subjects will receive Everolimus 10 mg daily Receives: Drug: Everolimus (RAD 001) |
| Placebo | Experimental | Subjects will receive double-blind placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Progression Free Survival Rate
Time to disease progression or death from any cause--2 year rate
Measured: 2 years
Secondary outcomes (8)
Number of Participants With Toxicity
Adverse event rate, any type, any grade regardless of attribution
Measured: 4 years
Site of Progression: Local-regional
Number of patients with local-regional progression
Measured: 4 years
Site of Progression: Distant
Number of patients with distant progression
Measured: 4 years
Site of Progression: Unknown
Number of patients with unknown site of progression
Measured: 4 years
Second Primary Tumor
Number of patients with second primary tumor
Measured: 4 years
Akt/mTOR Pathway Activation
mTOR positive in tumor tissue
Measured: Baseline
Correlation of Akt/mTOR Status With Progression-free Survival
mTOR positive in tumor tissue
Measured: 4 years
Determine if PTEN Status is a Predictive Biomarker
Differential effect of PTEN status on progression-free survival between the two arms
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2018
- Study completionOct 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Tanguy Seiwert, M.D., Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111058
- Sponsor's protocol ID
- 09-266-B
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2010
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nathan CO, Hayes DN, Karrison T, Harismendy O, Flores JM, Moore-Medlin T, Vokes EE, Gutkind JS, Neupane P, Mills G, Sargi Z, Seiwert T, Grilley-Olson J, Day T, Gillison M, Wade JL, Feldman L, Jha G, Kozloff M, O'Leary M, Worden FP, Cohen EEW. A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck. Clin Cancer Res. 2022 Dec 1;28(23):5040-5048. doi: 10.1158/1078-0432.CCR-21-4290.
PubMed 36194164
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01111058
- Acronym / sponsor ID
- 09-266-B
- Conditions
- Head and Neck Cancer
- Keywords
- Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Apr 2010
- Primary completion
- Apr 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus (RAD001) | Experimental | Drug: Everolimus (RAD 001)Subjects will receive Everolimus 10 mg daily |
| Placebo | Experimental | Other: PlaceboSubjects will receive double-blind placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus (RAD 001)10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first). | Drug | Everolimus (RAD001) |
| Placebo | Other | Placebo |
Primary outcome
2 Year Progression Free Survival Rate
Time frame: 2 years
Time to disease progression or death from any cause--2 year rate
8 secondary outcomes
Number of Participants With Toxicity
Time frame: 4 years
Site of Progression: Local-regional
Time frame: 4 years
Site of Progression: Distant
Time frame: 4 years
Site of Progression: Unknown
Time frame: 4 years
Second Primary Tumor
Time frame: 4 years
Akt/mTOR Pathway Activation
Time frame: Baseline
Correlation of Akt/mTOR Status With Progression-free Survival
Time frame: 4 years
Determine if PTEN Status is a Predictive Biomarker
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36194164Nathan CO, Hayes DN, Karrison T, Harismendy O, Flores JM, Moore-Medlin T, Vokes EE, Gutkind JS, Neupane P, Mills G, Sargi Z, Seiwert T, Grilley-Olson J, Day T, Gillison M, Wade JL, Feldman L, Jha G, Kozloff M, O'Leary M, Worden FP, Cohen EEW. A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck. Clin Cancer Res. 2022 Dec 1;28(23):5040-5048. doi: 10.1158/1078-0432.CCR-21-4290.
- The University of Chicago Comprehensive Cancer Center Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanguy Seiwert, M.D. principal investigator
The University of Chicago Medical Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus (RAD 001) in people with Head and Neck Cancer, run by University of Chicago at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Year Progression Free Survival Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01111058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.