• Six month survival
  
• Response rate
  

• Assessment of pharmacokinetics after oral administration
  
• Assessment of biologic activity in tumor and blood mononuclear cells via signalling and apoptotic pathways
  

Curcumin (diferuloyl methane) is the active compound in the dietary ingredient tumeric. Curcumin has potent irreversible antiproliferative effects against a variety of cancer cell lines in vitro and chemopreventive effects in murine carcinoma models. Furthermore, this compound demonstrates little in the way of toxicity in animals as well as in preliminary Phase I trials in humans. Taken together with the dismal therapeutic options available for pancreatic cancer patients, these results suggest that curcumin warrants investigation. We, therefore, propose to perform an exploratory clinical/translational trial of curcumin in patients with unresectable or metastatic pancreatic cancer. This trial will provide essential data on in vivo biological and clinical effects and pharmacology of curcumin in patients with pancreatic cancer, and should serve as a foundation for additional studies which incorporate curcumin in the adjuvant setting and/or combine it with chemotherapeutic/biologic agents in patients with pancreatic as well as other cancers.

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the pancreas that is not amenable to curative surgical resection, including locally advanced, metastatic, or recurrent disease.
• Performance status: Karnofsky greater or equal to 60
• Age equal to or greater than 18 years
• Absolute granulocyte count 1500/mm3 or greater
• Platelet count of 100,000/mm3 or greater
• Total bilirubin less than or equal to 2 x upper limit of normal
• Alkaline phosphatase less than or equal to 5 x upper limit of normal
• AST and/or ALT less than or equal to 5 x upper limit of normal
• Creatinine less than or equal to 2.0 mg/dl
• Measurable disease
• Patient must agree to use effective contraception, if applicable

Exclusion Criteria:

• History of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease
• Prior radiation treatment unless progression of disease within the radiated field or measurable disease outside the radiated field. Also must be at least four weeks from radiation and have recovered from all toxicities
• Unstable medical condition in the opinion of investigator, including uncontrolled diabetes mellitus, hypertension, active infections requiring systemic antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrhythmias, or unstable coagulation disorders.
• Pregnancy or breast-feeding
• Other investigational therapy within four weeks of study entry