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Trial of Curcumin in Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00094445
First Posted: October 19, 2004
Last Update Posted: April 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sabinsa Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
October 18, 2004
October 19, 2004
April 30, 2014
November 2004
April 2014   (Final data collection date for primary outcome measure)
Six-Month Participant Survival [ Time Frame: 6 months ]
Number of participants followed from baseline (date of randomization) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
  • Six month survival
  • Response rate
Complete list of historical versions of study NCT00094445 on ClinicalTrials.gov Archive Site
Not Provided
  • Assessment of pharmacokinetics after oral administration
  • Assessment of biologic activity in tumor and blood mononuclear cells via signalling and apoptotic pathways
Not Provided
Not Provided
 
Trial of Curcumin in Advanced Pancreatic Cancer
Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer
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.

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. During this study, you will receive much higher doses of curcumin than can be obtained from the diet.

During the study, you will receive curcumin by mouth every day. You will be required to take up to 16 pills per day each morning. Every 8-week period you take curcumin is considered a "course" of treatment. The number of courses you receive depends on how you are responding to treatment. You can continue treatment as long as the disease does not get worse. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

You will be given a questionnaire to complete at the beginning of the study and once a week while you are on therapy to help the medical staff understand how the different symptoms from your disease are affecting you. This questionnaire, which should take about 5 minutes to complete, can be done over the telephone or with the help of one of the study staff during your visits.

At the end of each course of treatment (every 8 weeks), you will have a physical exam and the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests.

This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreatic Neoplasms
  • Adenocarcinoma
Drug: Curcumin
8 gm per day
Other Name: diferuloyl methane
Experimental: Curcumin
8 gm per day
Intervention: Drug: Curcumin
Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00094445
ID03-0009
1R21CA104337 ( U.S. NIH Grant/Contract )
NCI-2012-01309 ( Registry Identifier: NCI CTRP )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Sabinsa Corporation
Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP