Status:
COMPLETED
Trial of Curcumin in Advanced Pancreatic Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sabinsa Corporation
Conditions:
Pancreatic Neoplasms
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 func...
Detailed Description
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory...
Eligibility Criteria
Inclusion
- 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.
- The patient has a Karnofsky Performance Status of greater than or equal to 60 at study entry.
- The patient has given informed consent.
- The patient is at least 18 years of age.
- 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.
- 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.
- The patient has measurable disease.
- The patient agrees to use effective contraception if procreative potential exists.
Exclusion
- The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease.
- 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.
- 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.
- The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.
- The patient has received an investigational agent(s) within four weeks of study entry.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00094445
Start Date
November 1 2004
End Date
April 1 2014
Last Update
August 28 2020
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030