Trial of Curcumin in Advanced Pancreatic Cancer
Condition: Pancreatic Neoplasms; Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Curcumin
Intervention description: Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer; Adenocarcinoma of the pancreas; Alternative therapy; Pancreas; Pancreatic Neoplasm; Cancer of the pancreas

Summary:

      The goal of this clinical research study is to learn if treatment with curcumin can help
      shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic
      cancer cells function and the safety of treatment with curcumin will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has pathologically confirmed adenocarcinoma of the pancreas that is not
             amenable to curative surgical resection (includes locally advanced, metastatic, or
             recurrent disease). Histology must be confirmed by the pathology department of the
             investigational center.

          2. The patient has a Karnofsky Performance Status of greater than or equal to 60 at study
             entry.

          3. The patient has given informed consent.

          4. The patient is at least 18 years of age.

          5. The patient has adequate hematologic function as defined by an absolute neutrophil
             count greater than or equal to 1,500/mm3, platelet count greater than or equal to
             100,000/mm3.

          6. The patient has adequate hepatic function as defined by a total bilirubin less than or
             equal to 2.0 X ULN, alkaline phosphatase, AST and/or ALT less than or equal to 5 X
             ULN, and creatinine less than or equal to 2.0 mg/dL.

          7. The patient has measurable disease.

          8. The patient agrees to use effective contraception if procreative potential exists.

        Exclusion Criteria:

          1. The patient has a history of treated or active brain metastases, carcinomatous
             meningitis, an uncontrolled seizure disorder, or active neurological disease.

          2. The patient has received prior radiation. Patients with measurable disease outside the
             radiation port or documented disease progression of previously irradiated measurable
             disease are eligible. Patient must be greater than or equal to four weeks post-therapy
             and have recovered from all toxicities.

          3. The patient has an unstable medical condition according to the investigator, including
             uncontrolled diabetes mellitus or hypertension; active infections requiring systemic
             antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrythmias, or
             unstable coagulation disorders.

          4. The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.

          5. The patient has received an investigational agent(s) within four weeks of study entry.