Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer

Inclusion Criteria:

• The patient is at least 18 years of age.

• The patient has histologically or cytologically confirmed, non-resectable, StageII-IV primary adenocarcinoma of the pancreas.

• The patient has had a baseline computed tomography (CT) scan, or magnetic resonanceimaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.

• The patient has never been treated with prior chemotherapy, with the exception oflow-dose 5-fluorouracil (5-FU) as a radiation sensitizer.

• The patient has sufficiently recovered from the effects of previous surgery (no lessthan 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no lessthan 4 weeks prior to randomization).

• The patient's estimated life expectancy is at least 12 weeks.

• The patient has a Karnofsky Performance Status between 50 and 100.

• The patient has adequate bone marrow function.

• The patient has adequate hepatic and renal function.

Exclusion Criteria:

• The patient has any active, uncontrolled infection requiring antibiotics.

• The patient has any serious, uncontrolled concomitant systemic disorder.

• The patient has surgery scheduled within 8 weeks following initiation of treatment.

• The patient is pregnant or nursing.

• The patient is not capable of consistent oral intake of at least 3 L/day of fluidand/or requires constant intravenous (IV) hydration or frequent tube feeding.

• The patient is receiving any investigational agent(s) or has been a participant in aclinical trial within the last 30 days.