Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after cetuximab-containing therapy (please see attached schema).
The primary endpoint is ORR. Progression and response will be assessed by RECIST. Patients will continue until PD or intolerable toxicity. Exploratory laboratory correlates are described below.
Squamous Cell Carcinoma Of The Head And Neck
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma of The Head and Neck After Cetuximab-Containing Chemoradiotherapy|
- Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]To study efficacy of dasatinib plus cetuximab, as measured by overall response rate (ORR) in order to determine whether or not dasatinib plus cetuximab is recommended for further study in SCCHN.
- Time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]To estimate time to progression and overall survival.
- The maximum toxicity for each category of interest in each subject [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]To evaluate the safety of the combination of dasatinib (D) and cetuximab (C) in this patient population. The maximum toxicity for each category of interest will be recorded for each patient and the summary results will be presented in tabular form.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Patients must have recurrent SCCHN and may have received any number of prior palliative systemic therapies for recurrent disease (without cetuximab or othr EGFR inhibitor). One prior curative regimen (induction, primary or postoperative chemoradiotherapy) should have been given AND all patients should have been exposed to cetuximab as part of prior potentially curative treatment (i.e. with radiotherapy or induction therapy). The last cetuximab dose should be > 3 months. Those who have received a prior Src kinase inhibitor or EGFR inhibitor other than cetuximab are not eligible.
|Contact: Rita Johnson, RNemail@example.com|
|Contact: Mary McDonough, BSNfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: RIta Johnson, RN 412-647-8571 email@example.com|
|Principal Investigator: Michael Gibson, MD|