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, Stage II-IV primary adenocarcinoma of the pancreas.
* The patient has had a baseline computed tomography (CT) scan, or magnetic resonance imaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.
* The patient has never been treated with prior chemotherapy, with the exception of low-dose 5-fluorouracil (5-FU) as a radiation sensitizer.
* The patient has sufficiently recovered from the effects of previous surgery (no less than 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no less than 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 fluid and/or requires constant intravenous (IV) hydration or frequent tube feeding.
* The patient is receiving any investigational agent(s) or has been a participant in a clinical trial within the last 30 days.