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 12-week PFS.
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 Patients With Cetuximab-resistant, Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck and Low Serum IL-6|
- Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]To evaluate the efficacy of the combination of cetuximab and dasatinib in patients with cetuximab-resistant, recurrent/metastatic SCCHN and low serum IL-6, as measured by 12-week PFS.
- 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 2013|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: CETUXIMAB AND DASATINIB
Cetuximab on a standard weekly schedule (see Section 6.2). Group 1 (subjects more than 2 weeks post last dose of Cetuximab): Loading dose of 400 mg/m2 on cycle 1, day 1 then 250 mg/m2 IV weekly.
Group 2 (subjects last Cetuximab treatment within 2 weeks): Cycle 1 will start at a dose of 250 mg/m2 Dasatinib 150 mg once daily without interruption. On the FIRST cycle (1 cycle is 3 weeks) dasatinib will start 3 days after the cetuximab loading dose (i.e. cycle 1, day 4) to avoid headache as shown on the previous phase I trial.
Treatment will continue until progression.
Cetuximab 250 mg/m2 IV weekly after loading dose 400 mg/m2 on cycle 1, day 1
Other Name: ErbituxDrug: Dasatinib
Dasatinib 150 mg po
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.Those who have received a prior Src kinase inhibitor or EGFR inhibitor other than cetuximab are not eligible.
Patients will be tested for serum IL-6. If IL-6 is detectable, the patient will be ineligible. If IL-6 is not detected, the patient will be eligible for the study. Subjects more than 2 weeks post last dose of Cetuximab will receive an initial loading dose 400 mg/m2 on cycle 1, day 1. Subjects who have received Cetuximab within 2 weeks of starting study will start Cycle 1 with dose of 250 mg/m2. Dasatinib will start 3 days after initial cetuximab study dose on cycle 1 (i.e cycle 1, day 4), and continue without interruption.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488318
|Contact: Rita Johnson, RNemail@example.com|
|Contact: Wieping DeBlasio, RNfirstname.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: Julie Bauman, MD|
|Principal Investigator:||Julie Bauman||University of Pittsburgh|