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Trial of Curcumin in Advanced Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00094445   Information provided by M.D. Anderson Cancer Center
First Received: October 18, 2004   Last Updated: February 20, 2009   History of Changes

October 18, 2004
February 20, 2009
November 2004
December 2009   (final data collection date for primary outcome measure)
  • To learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • To study the effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Six month survival
  • Response rate
Complete list of historical versions of study NCT00094445 on ClinicalTrials.gov Archive Site
 
  • Assessment of pharmacokinetics after oral administration
  • Assessment of biologic activity in tumor and blood mononuclear cells via signalling and apoptotic pathways
 
Trial of Curcumin in Advanced Pancreatic Cancer
Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer

Objectives:

The objectives of the trial will be to:

(I) Evaluate six month survival and response rates.

(II) Evaluate side effects of curcumin in patients with pancreatic cancer.

(III) Assess pharmacokinetics of curcumin after oral administration in this population.

(IV) Assess biologic activity of this molecule in both tumor and surrogate tissues (peripheral blood mononuclear cells) including baseline and post-therapy effects on signaling and apoptosis.

(V) Longitudinally assess patient symptom burden (prevalence, severity, patterns of symptoms) over the course of the trial.

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.

Before treatment starts, you will be asked questions about your medical history. You will have a complete physical exam, including measurement of your height, weight, temperature, pulse, breathing rate, and blood pressure. You will have a CT scan and/or MRI scan to evaluate the tumor. You will be asked questions about the tumor and any symptoms related to the disease. Women who are able to have children must have a negative blood or urine pregnancy test.

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.

Phase II
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
  • Pancreatic Neoplasms
  • Adenocarcinoma
Drug: Curcumin
Experimental: 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 National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
June 2007
December 2009   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00094445
Razelle Kurzrock,MD, BS, UT MD Anderson Cancer Center
ID03-0009, 1R21CA104337
M.D. Anderson Cancer Center
 
Principal Investigator: Razelle Kurzrock, MD U.T. M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2009

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