Colorectal Cancer Clinical Trial
Official title:
A Phase I Study of Lapatinib and Cetuximab in Patients With Solid Tumors
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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