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

Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.

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.