A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer

Inclusion Criteria:

- Histologically documented Stage IV metastatic adenocarcinoma of the pancreas with
measurable disease

- Performance status ECOG 0 or 1

- Patients may not have received prior treatment for metastatic pancreatic
adenocarcinoma except for receiving gemcitabine or 5FU as a radiosensitizer along
with radiation therapy; or have received gemcitabine for adjuvant treatment if they
have been off gemcitabine for > 12 months

- Adult (>18 years of age) male or non-pregnant and non-lactating female

- A negative serum pregnancy test (Beta-hCG) documented within 72 hours of the first
administration of study drug in female patients of child-bearing potential

- Agreement to use contraception considered adequate and appropriate by the
investigator

- The following blood counts at baseline:

- ANC >/= 1.5 x 109/L

- Hgb > 9g/dL

- Platelets >100 x 109/L

- The following blood chemistry levels at baseline:

- AST and ALT metastasis are present

- Bilirubin
- Serum creatinine within 1.5 x ULN

- PT, INR within 1.5 x ULN unless on therapeutic doses of warfarin

- Must have measurable disease outside the pancreas by RECIST criteria

- No clinically significant abnormalities in urinalysis results

- Voluntary agreement to participate in this study after being informed about the
nature of the study including potential risks and benefits and having the ability to
have questions addressed. The patient must sign and date the IRB approved Informed
Consent Form (ICF) prior to participation in any study-related procedures

Exclusion Criteria:

- Has pancreatic islet cell neoplasms

- Is pregnant or lactating

- Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy

- Known infection with HIV, Hepatitis B or Hepatitis C.

- Patient with a history of interstitial lung disease, history of slowly progressive
dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary
fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies (see section
4.4.9)

- Has a serious medical risk factor(s) involving any of the major organ systems such
that the investigator considers it unsafe for the patient to receive an experimental
research drug.

- Is unwilling or unable to comply with study procedures.

- Is enrolled in any other investigational trial.

Caution of observation for interstitial pneumonitis in patients prior to enrollment:

Before enrollment, evaluate candidate patients fro familial, environmental or occupational
exposure to opportunistic pathogens, and do not enroll those with a history of slowly
progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis,
silicosis. idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or
multiple allergies.