Trial of Curcumin in Advanced Pancreatic Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00094445

Purpose

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.

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Curcumin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Enrollment:	50
Study Start Date:	November 2004
Estimated Study Completion Date:	June 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Curcumin	Drug: Curcumin 8 gm per day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094445

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Razelle Kurzrock, MD

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

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.

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:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00094445 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Pancreatic Cancer
Adenocarcinoma of the pancreas
Alternative therapy

Pancreas
Pancreatic Neoplasm
Cancer of the pancreas

Study placed in the following topic categories:

Anti-Inflammatory Agents
Digestive System Neoplasms
Curcumin
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Carcinoma
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms

Pancreatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Antirheumatic Agents
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 02, 2009