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Phase II Trial Of Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma of The Head and Neck After Cetuximab-Containing Chemoradiotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma Of The Head And Neck

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Trial Information

Phase II Trial Of Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma of The Head and Neck After Cetuximab-Containing Chemoradiotherapy


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.


Inclusion Criteria:



- Patients must have recurrent SCCHN that has been previously treated with cetuximab as
part of potentially curative therapy (i.e. with induction therapy, radiotherapy or
chemoradiotherapy). The interval from completion of cetuximab and study treatment
should be >3 months.

- Measurable disease per RECIST 1.1.

- 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.

- Unlimited prior treatment with radiation or chemoradiotherapy

- Any number of prior regimens for recurrent or metastatic SCCHN (i.e. palliative
treatment) but without cetuximab or another EGFR inhibitor

- Age > or equal to 18 years

- ECOG performance status < or equal to 2

- Life expectancy of greater than 12 weeks.

- Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count > or equal to 1,200/µL

- platelets > or equal to 100,000/µL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) < or equal to 2.5 X institutional upper limit normal

- Creatinine up to 1.5 X normal institutional limits

- Ability to understand and the willingness to sign a written informed Consent
document.

- Patients should not be taking concomitant medication that are CYP3A4 inducers or
potent inhibitors (+++) and should try to avoid taking proton pump inhibitors and H2
antagonists during rest of treatment period. The above medications will be continued
only if medically necessary and their use will be noted.

- Sexually active women of childbearing potential must use an effective method of birth
control during the course of the study, in a manner such that risk of failure is
minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be
advised of the importance of avoiding pregnancy during trial participation and the
potential risk factors for an unintentional pregnancy. In addition, men enrolled on
this study should understand the risks to any sexual partner of childbearing
potential and should practice an effective method of birth control. All WOCBP MUST
have a negative pregnancy test prior to first receiving investigational product. If
the pregnancy test is positive, the patient must not receive investigational product
and must not be enrolled in the study. In addition, all WOCBP should be instructed to
contact the Investigator immediately if they suspect they might be pregnant (e.g.,
missed or late menstrual period) at any time during study participation.

Exclusion Criteria:

- Prior treatment with an EGFR inhibitor other than cetuximab at any time

- Prior treatment with an EGFR inhibitor as part of a regimen for recurrent or
metastatic SCCHN.

- Prior treatment with SFK inhibitor at any time

- Patients who have not recovered from adverse events due to prior agents. A minimum
interval of 3 weeks should have elapsed from prior radiotherapy and/or chemotherapy

- Patients may not have received an investigational agent within 4 weeks of starting
this trial.

- Patients with untreated brain metastases should be excluded from this clinical trial

- History of allergic reactions to monoclonal antibodies.

- Inability to swallow oral medications (unless patients use a feeding tube in which
case they are eligible).

- Uncontrolled angina or uncontrolled hypertension or any history of clinically
significant ventricular arrhythmias (such as ventricular tachycardia, ventricular
fibrillation, or Torsades de pointes).

- Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) on the Bazett's
correction.

- Diagnosed or suspected congenital long QT syndrome.

- Patients currently taking drugs that are generally accepted to have a risk of causing
Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone,
sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine,
haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol,
methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl,
pentamidine, sparfloxacin, lidoflazine.

- Any other uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, or psychiatric illness/social
situations that would limit compliance with study requirements.

- History of significant bleeding disorder unrelated to cancer, including: diagnosed
congenital bleeding disorders (e.g., von Willebrand's disease), diagnosed acquired
bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

08-034

NCT ID:

NCT01488318

Start Date:

October 2011

Completion Date:

May 2014

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Cetuximab
  • Dasatinib
  • Squamous Cell
  • Head and Neck
  • After Cetuximab Containing Chemoradiotherapy
  • Recurrent
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213