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| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 2004 | ||||
| Last Updated Date | February 20, 2009 | ||||
| Start Date ICMJE | November 2004 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00094445 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Curcumin in Advanced Pancreatic Cancer | ||||
| Official Title ICMJE | Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer | ||||
| Brief Summary | 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. |
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| 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. 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Curcumin | ||||
| Study Arms / Comparison Groups | Experimental: Curcumin | ||||
| Publications * | Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98. Review. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | June 2007 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00094445 | ||||
| Responsible Party | Razelle Kurzrock,MD, BS, UT MD Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | ID03-0009, 1R21CA104337 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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