Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer
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 = 1 due to prior chemotherapy
- 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