Everolimus Versus Placebo in Head and Neck Cancer

• Status: Terminated
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

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.