Everolimus Versus Placebo in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01111058
• Other study ID #: 09-266-B
• Status: Terminated
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: October 2018

Study information

• Verified date: March 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Everolimus (RAD 001)
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois-Chicago	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	University of Mississippi	Jackson	Mississippi
United States	University of Kansas	Kansas City	Kansas
United States	University of Miami	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Washington University	Saint Louis	Missouri
United States	Louisianna State University	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 Year Progression Free Survival Rate	Time to disease progression or death from any cause--2 year rate	2 years
Secondary	Number of Participants With Toxicity	Adverse event rate, any type, any grade regardless of attribution	4 years
Secondary	Site of Progression: Local-regional	Number of patients with local-regional progression	4 years
Secondary	Site of Progression: Distant	Number of patients with distant progression	4 years
Secondary	Site of Progression: Unknown	Number of patients with unknown site of progression	4 years
Secondary	Second Primary Tumor	Number of patients with second primary tumor	4 years
Secondary	Akt/mTOR Pathway Activation	mTOR positive in tumor tissue	Baseline
Secondary	Correlation of Akt/mTOR Status With Progression-free Survival	mTOR positive in tumor tissue	4 years
Secondary	Determine if PTEN Status is a Predictive Biomarker	Differential effect of PTEN status on progression-free survival between the two arms	4 years

External Links

•   The University of Chicago Comprehensive Cancer Center Web Page