Lung Cancer Clinical Trial
Lapatinib and Cetuximab in Patients With Solid Tumors
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 Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time.
In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.
Eligibility Criteria
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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Washington District of Columbia, 20007, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.