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Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Neoplasms, Adenocarcinoma

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Trial Information

Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer

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.

Inclusion Criteria:

1. 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.

2. The patient has a Karnofsky Performance Status of greater than or equal to 60 at
study entry.

3. The patient has given informed consent.

4. The patient is at least 18 years of age.

5. 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

6. 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.

7. The patient has measurable disease.

8. The patient agrees to use effective contraception if procreative potential exists.

Exclusion Criteria:

1. The patient has a history of treated or active brain metastases, carcinomatous
meningitis, an uncontrolled seizure disorder, or active neurological disease.

2. 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.

3. 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.

4. The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.

5. The patient has received an investigational agent(s) within four weeks of study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-Month Participant Survival

Outcome 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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Vivek Subbiah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

November 2014

Related Keywords:

  • Pancreatic Neoplasms
  • Adenocarcinoma
  • Pancreatic Cancer
  • Adenocarcinoma of the pancreas
  • Alternative therapy
  • Pancreas
  • Pancreatic Neoplasm
  • Cancer of the pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Pancreatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030