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Clinical Trial NU UC10N01

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)
Principal Investigator
Mark Agulnik
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.NU UC10N01
Purpose
To determine two-year PFS probability in subjects treated w/ everolimus v placebo after definitive local therapy.
Overview
The purpose of this clinical research study is to see if Everolimus helps keep advanced squamous cell carcinoma of the head and neck (SCCHN) from coming back after a patient completes regular treatment. Currently there is no known or proven intervention or drug that can reduce the risk of SCCHN from coming back after regular treatment is completed. Everolimus is approved by the U.S. Food and Drug Administration (FDA) to treat kidney cancer, but has not been approved for other types of cancer. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body.
Eligibility
Some of the eligibility criteria include:
  • Participants must not be currently receiving anticancer therapies or have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
  • Participants must be 18 years or older.
  • Participants must have squamous cell carcinoma of the head and neck that is pathologically confirmed
  • Participants must have no evidence of disease (NED) within 16 weeks after receiving curative intent therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
If a patient is eligible and agrees to participate in the study, they will be randomly assigned (like the flip of a coin) to one of 2 study groups: Group 1 Subjects will receive tablets that contain Everolimus and Group 2 Subjects will receive tablets with no active drug (a placebo). While on study, patients will take the study drug, either Everolimus or placebo by mouth once a day (2 tablets each time) for up to 1 year, until their cancer returns, or the physician decides to take you off study.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 20-Dec-14 03:42 AM

 

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