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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA104337 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-01309 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Sabinsa Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin | Experimental | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug | 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 \ |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Month Participant Survival | 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Subbiah, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12680238 | Background | Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center | View source |
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1 participant did not receive treatment due to screen failure, patient withdrew the consent
Recruitment Period: November 12, 2004 to November 11, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Curcumin | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Curcumin | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Six-Month Participant Survival | 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. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Curcumin | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI hemmorhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| edema | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivek Subbiah, MD / Assistant Professor, Investigational Cancer Therapeutics | University of Texas (UT) MD Anderson Cancer Center | 713-563-0393 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 9 |
| 44 |
| 6 |
| 44 |
| Chest pain | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Multiple pulmonary emboli | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| chronic cancer progression | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| abdomen pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| acute renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| metastasis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| weakness | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| dehydration | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| slurred speech | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| confusion | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| non-neutropenic fever | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| mood alteration | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Chronic colocutaneous fistula | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| abdominal wall abscess | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| atrial flutter | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| indigestion | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| abdomen | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| depression | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |