Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy

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.