Conditions: Pancreas Cancer
Keywords: Pancreas cancer lapatinib capecitabine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Treatment

Interventions: intervention 1: Lapatinib and Capecitabine
Intervention descriptions: intervention 1: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles

Protocol document: