Pancreas Cancer Clinical Trial
Official title:
Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer
Patients are being asked to participate in this study who have locally advanced or
metastatic pancreatic cancer (cancer of the pancreas that has spread to another part of the
body) that has gotten worse after first-line chemotherapy.
The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two
chemotherapy agents), prolong survival and improve quality of life as compared to supportive
care alone.
Lapatinib in combination with a drug called capecitabine, has been approved by the Food and
Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been
approved to treat this type of cancer. Both of these drugs are pills.
This research is being done because it is not known if the combination of Capecitabine and
Lapatinib is better than supportive care alone for pancreatic cancer.
This is an open-label single-arm Phase II trial for patients with metastatic pancreatic cancer who have failed first line Gemcitabine-based therapy. Patients will be treated with a combination of Capecitabine and Lapatinib, a dual tyrosine-kinase inhibitor of EGFR and HER-2. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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