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A Phase I Study of Lapatinib and Cetuximab in Patients With Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer, Lung Cancer, Head and Neck Cancer

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Trial Information

A Phase I Study of Lapatinib and Cetuximab in Patients With Solid Tumors

Inclusion Criteria:

- At least one measurable lesion by RECIST criteria

- A tumor lesion that can be readily biopsied using a core needle via clinical exam,
ultrasound, CT, or fluoroscopic-guidance

- Over the age of 18 years and able to provide informed consent

- Patients must have progressed after standard therapy for metastatic/ recurrent
disease including 5-FU containing regimens for patients with colorectal cancer, and
platinum-containing regimens for patients with head and neck cancer and non-small
cell lung cancer.

- Patients may have received cetuximab, panitumumab or erlotinib previously

- Adequate kidney, liver, and bone marrow function

- Life expectancy greater than 3 months

- ECOG performance status
- Normal left ventricular ejection fractions

Exclusion Criteria:

- Chemotherapy or surgery within 4 weeks prior to treatment start

- Radiation treatment within 3 weeks prior to treatment start

- Prior therapy with lapatinib

- Untreated brain metastasis or neurologically unstable CNS metastases

- Any severe or uncontrolled medical condition or other condition that could affect
participation in this study including unstable angina, serious uncontrolled cardiac
arrhythmia, uncontrolled infection, or myocardial infarction study entry

- Diarrhea > grade 1 at baseline

- Patients on a medication or herbal therapy known to inhibit CYP3A4

- Gastrointestinal tract disease resulting in the inability to take oral medication or
a requirement for IV alimentation, prior surgical procedures affecting absorption or
active peptic ulcer disease

- Ongoing ventricular cardiac dysrhythmias of grade >/= 2

- Subjects with a history of serious ventricular arrhythmia (ventricular tachycardia or
ventricular fibrillation >= 3 beats in a row)

- Serious cardiac arrhythmia requiring medication

- QTc interval > 500 msec

- Female patients who are pregnant or breast feeding, or adults who are of reproductive
potential and are unwilling to refrain from conceiving a child during study treatment

- Patients unwilling or unable to comply with the protocol or provide informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Description:

The dose at which

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

John F Deeken, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown Univeristy Medical Center


United States: Food and Drug Administration

Study ID:

tykerb-itux 1



Start Date:

June 2010

Completion Date:

October 2014

Related Keywords:

  • Colorectal Cancer
  • Lung Cancer
  • Head and Neck Cancer
  • recurrent colorectal cancer
  • recurrent head and neck cancer
  • recurrent lung cancer
  • cetuximab
  • lapatinib
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms



Georgetown University Medical Center Washington, District of Columbia  20007