Status:
COMPLETED
Lapatinib and Cetuximab in Patients With Solid Tumors
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Colorectal Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth...
Eligibility Criteria
Inclusion
- 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 \</= 2
- Normal left ventricular ejection fractions
Exclusion
- 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 \</= 6 months prior to 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01184482
Start Date
June 1 2010
End Date
September 1 2013
Last Update
October 31 2013
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007