Lapatinib and Capecitabine for Second Line Treatment of Pancreas 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.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the pancreas

- Prior failed 1st line gemcitabine therapy for metastatic disease or relapsed within
six months of completion of gemcitabine adjuvant therapy

- Prior capecitabine or 5fu is allowed in the setting of radiation

- Must either be able to swallow or receive enteral nutrition via gastrostomy feeding
tube

- Cardiac ejection fraction within institutional range of normal as measured by
echocardiogram

- ECOG performance status 0-2

- Signed informed consent form

- Adequate hepatic, bone marrow, and renal function

Exclusion Criteria:

- Any prior treatment with lapatinib, or any anti-HER2 treatment or any anti-EGFR
treatment

- Not recovered from adverse events to a toxicity grade
- More than one prior chemotherapy regimens

- Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple
sclerosis

- HIV positive on antiretroviral therapy

- Pregnant or lactating

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to lapatinib or capecitabine

- Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative
colitis)

- Known history of uncontrolled or symptomatic angina, arrhythmia, or congestive heart
failure

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/ social situations that would limit compliance with
study requirements

- Known dihydropyrimidine dehydrogenase deficiency

- Concurrent malignancy unless the subject has been curatively treated and disease free
for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer.

- Creatinine clearance < 30 mL/min

- Absolute neutrophil count < 1500, platelets < 75,000

- Transaminases > 3.0 times the upper limit of normal, except in known hepatic
metastasis, wherein they must be < 5.0 times the upper limit of normal

- Total bilirubin > 1.5 times the ULN, > 2.5 x ULN if patient has Gilbert's syndrome