Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer
This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.
Head and Neck Cancer
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer|
- To establish the safety and tolerability of CUDC-101 when administered in combination with concurrent cisplatin and radiation in subjects with locally advanced head and neck cancers. [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]Safety and tolerability will be assessed by the number of participants with adverse events and will determine the maxiumum tolerated dose of CUDC-101 in combination with cisplatin and radiation.
- To evaluate the efficacy of CUDC-101, cisplatin and radiation combination therapy. [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]Efficacy of CUDC-101 will be determined by the number of subjects disease free at the completion of the treatment period and the number of subjects remaining disease free in the follow up period.
- To assess the pharmacokinetics of CUDC-101. [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]Pharmacokinetics will involve a determination of the concentration of CUDC-101 in the blood over time.
- To evaluate the pharmacodynamic effects of CUDC-101. [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]The ability of CUDC-101 to exert a biological effect on the tumor will be examined in pharmacodynamic samples.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Louisiana|
|Overton Brooks VA Medical Center|
|Shreveport, Louisiana, United States, 71101|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 01911|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|