Clinical Trial NU UC10N01
- 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
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU UC10N01
- To determine two-year PFS probability in subjects treated w/ everolimus v placebo after definitive local therapy.
- 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.
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).
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Mark Agulnik
- TPF Induction chemotherapy and ABT-888 (Veliparib) – a Phase 1/Randomized Phase 2 Study in Patients w/ Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
- Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
- Phase 2 Efficacy and Safety Study of Intravenous GPX-150, an Anthracycline Analog, in Patients with Soft Tissue Sarcoma
- An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients with Advanced Soft Tissue Sarcoma
- A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
- A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
last updated: 18-Apr-15 03:47 PM
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