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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

2 year Tumor Progression free survival

Outcome Description:

Subjects will be treated for a maximum of 1 year and followed for progression (tumor growth) or 2 years (whichever comes first).

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ezra E. Cohen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Chicago Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

09-266-B

NCT ID:

NCT01111058

Start Date:

April 2010

Completion Date:

June 2016

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
University of MinnesotaMinneapolis, Minnesota  55455
Vanderbilt UniversityNashville, Tennessee  37232-6305
University of North CarolinaChapel Hill, North Carolina  27599
Northwestern UniversityChicago, Illinois  60611
The University of Chicago Medical CenterChicago, Illinois  60637-1470
Ohio State UniversityColumbus, Ohio  43210
Washington UniversitySt. Louis, Missouri  63110
Tufts Medical CenterBoston, Massachusetts  02111
University of MiamiMiami, Florida  33136
Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina  29425
University of MississippiJackson, Mississippi  39216
The University of Texas Medical Branch at GalvestonGalveston, Texas  77550
University Of KansasKansas City, Kansas  66160
Ingalls Cancer Research CenterHarvey, Illinois  60426
Louisianna State UniversityShreveport, Louisiana  71130
University of Illinois-ChicagoChicago, Illinois  60612