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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00094445 |
Purpose
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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms Adenocarcinoma |
Drug: Curcumin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | June 2007 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Curcumin: Experimental |
Drug: Curcumin
8 gm per day
|
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. Curcumin will be provided free of charge during the study. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susan R Pilat, B.S.N. | 713-745-3296 | spilat@mdanderson.org |
| Contact: Kehr Kathy, P.A. | 713-745-5378 | kkehr@mdanderson.org |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Razelle Kurzrock, M.D. 713-794-1226 rkurzroc@mdanderson.org | |
| Contact: Susan R Pilat, B.S.N. 713-745-3296 spilat@mdanderson.org | |
| Principal Investigator: Razelle Kurzrock, MD, FACP | |
| Sub-Investigator: James L Abbruzzese, M.D. | |
| Principal Investigator: | Razelle Kurzrock, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Razelle Kurzrock,MD, BS ) |
| Study ID Numbers: | ID03-0009, 1R21CA104337 |
| Study First Received: | October 18, 2004 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00094445 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreatic Cancer Adenocarcinoma of the pancreas Alternative therapy |
Pancreas Pancreatic Neoplasm Cancer of the pancreas |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Endocrine Gland Neoplasms Curcumin Digestive System Neoplasms Neoplasms by Histologic Type |
Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Pancreatic Diseases Peripheral Nervous System Agents Adenocarcinoma Antirheumatic Agents Central Nervous System Agents Neoplasms, Glandular and Epithelial |
