Trial of Curcumin in Advanced Pancreatic Cancer

NCT00094445 | Completed Phase 2 Results

• 3 other identifiers: ID03-00091R21CA104337NCI-2012-01309
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Keywords

Pancreatic Cancer; Adenocarcinoma of the pancreas; Alternative therapy; Pancreas; Pancreatic Neoplasm; Cancer of the pancreas

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Curcumin

EXPERIMENTAL

Oral curcumin daily for eight weeks, starting dose 8 gm per day.

Drug: Curcumin

Interventions

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 \</= 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.

Also known as: diferuloyl methane

Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sabinsa Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Aggarwal BB, Kumar A, Bharti AC. Anticancer potential of curcumin: preclinical and clinical studies. Anticancer Res. 2003 Jan-Feb;23(1A):363-98.

  PMID: 12680238 BACKGROUND

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Vivek Subbiah, MD / Assistant Professor, Investigational Cancer Therapeutics
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-0393

Study Officials

• Vivek Subbiah, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2004
• First Posted: October 19, 2004
• Study Start: November 1, 2004
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 28, 2020
• Results First Posted: August 28, 2020

Record last verified: 2020-08

Locations

US (1)