Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT01488318|
Recruitment Status : Terminated (PI leaving the institution)
First Posted : December 8, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma Of The Head And Neck||Drug: Cetuximab Drug: Dasatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||August 2016|
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: Erbitux
Dasatinib 150 mg po
- Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Response to Treatment [ Time Frame: Up to 36 months ]Response of evaluable patients to treatment, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]
- Overall Survival (OS) [ Time Frame: Up to 60 months ]From date of entry into the study until the date of death from any cause, assessed up to 60 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488318
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Julie Bauman||University of Pittsburgh|