Trial of Curcumin in Advanced Pancreatic Cancer
Study Details
Study Description
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 function and the safety of treatment with curcumin will also be studied.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Curcumin Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
Drug: Curcumin
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 </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Six-Month Participant Survival [Baseline to 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UT MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- Sabinsa Corporation
Investigators
- Principal Investigator: Vivek Subbiah, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- ID03-0009
- 1R21CA104337
- NCI-2012-01309
Study Results
Participant Flow
| Recruitment Details | Recruitment Period: November 12, 2004 to November 11, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center. |
|---|---|
| Pre-assignment Detail | 1 participant did not receive treatment due to screen failure, patient withdrew the consent |
| Arm/Group Title | Curcumin |
|---|---|
| Arm/Group Description | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Period Title: Overall Study | |
| STARTED | 50 |
| COMPLETED | 44 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Curcumin |
|---|---|
| Arm/Group Description | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Overall Participants | 50 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
65
|
| Sex: Female, Male (Count of Participants) | |
| Female |
28
56%
|
| Male |
22
44%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
47
94%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
4
8%
|
| Not Hispanic or Latino |
46
92%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
50
100%
|
Outcome Measures
| Title | Six-Month Participant Survival |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Curcumin |
|---|---|
| Arm/Group Description | Oral curcumin daily for eight weeks, starting dose 8 gm per day. |
| Measure Participants | 44 |
| Count of Participants [Participants] |
7
14%
|
Adverse Events
| Time Frame | 3 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Curcumin | |
| Arm/Group Description | Oral curcumin daily for eight weeks, starting dose 8 gm per day. | |
All Cause Mortality |
||
| Curcumin | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Curcumin | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/44 (20.5%) | |
| Cardiac disorders | ||
| Chest pain | 1/44 (2.3%) | |
| Multiple pulmonary emboli | 1/44 (2.3%) | |
| atrial fibrillation | 1/44 (2.3%) | |
| atrial flutter | 1/44 (2.3%) | |
| Gastrointestinal disorders | ||
| GI hemmorhage | 1/44 (2.3%) | |
| chronic cancer progression | 1/44 (2.3%) | |
| abdomen pain | 2/44 (4.5%) | |
| metastasis | 1/44 (2.3%) | |
| ascites | 1/44 (2.3%) | |
| constipation | 1/44 (2.3%) | |
| vomiting | 1/44 (2.3%) | |
| Chronic colocutaneous fistula | 1/44 (2.3%) | |
| abdominal wall abscess | 1/44 (2.3%) | |
| indigestion | 1/44 (2.3%) | |
| General disorders | ||
| weakness | 1/44 (2.3%) | |
| dehydration | 1/44 (2.3%) | |
| non-neutropenic fever | 1/44 (2.3%) | |
| Pain | 1/44 (2.3%) | |
| Infections and infestations | ||
| infection | 1/44 (2.3%) | |
| Metabolism and nutrition disorders | ||
| anorexia | 3/44 (6.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| musculoskeletal | 1/44 (2.3%) | |
| Nervous system disorders | ||
| slurred speech | 1/44 (2.3%) | |
| confusion | 1/44 (2.3%) | |
| mood alteration | 1/44 (2.3%) | |
| Renal and urinary disorders | ||
| acute renal failure | 1/44 (2.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Curcumin | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/44 (13.6%) | |
| Gastrointestinal disorders | ||
| vomiting | 2/44 (4.5%) | |
| nausea | 2/44 (4.5%) | |
| abdomen | 1/44 (2.3%) | |
| General disorders | ||
| Fatigue | 1/44 (2.3%) | |
| Nervous system disorders | ||
| depression | 1/44 (2.3%) | |
| Skin and subcutaneous tissue disorders | ||
| edema | 4/44 (9.1%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Vivek Subbiah, MD / Assistant Professor, Investigational Cancer Therapeutics |
|---|---|
| Organization | University of Texas (UT) MD Anderson Cancer Center |
| Phone | 713-563-0393 |
| CR_Study_Registration@mdanderson.org |
- ID03-0009
- 1R21CA104337
- NCI-2012-01309