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Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer
This study is not yet open for participant recruitment.
Verified by Tel-Aviv Sourasky Medical Center, February 2006
Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00295035
  Purpose

Colorectal cancer is a major health concern in the Western world with an estimated lifetime risk of 5-6%. The goal of achieving effective cancer prevention is driven by the prediction that CRC will become the leading cause of death (surpassing heart disease) in this decade, with an estimated 1,000,000 new cases and over 500,000 deaths per year, worldwide. Despite continuing advances in diagnosis and therapy, long-term survival rates have not improved significantly over the last four decades. Nearly 50% of all CRC patients will die of the disease. Preventive strategies offer the best hope, at least until our understanding of the biology of cancer matures to the point where it can be implemented into therapy. The search for new chemopreventive compounds with minimal toxicity raises particular interest in phytochemicals.Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of Curcuma Longa, an East Indian plant, commonly called turmeric. It has been shown to possess potent anti-inflammatory and anti-oxidative properties, for which it has a long history of dietary use as a food additive. Curcumin has also a potent anti-proliferative effects against a variety of cancer cell lines in vitro, which stem from its ability to modulate many intracellular signal transduction pathways. Human phase I-II studies found curcumin to be safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day. This data, together with the dismal therapeutic options available for colon cancer patients, suggest that curcumin warrants investigation in this setting. The present study evaluates gemcitabine in combination with curcumin and celecoxib for patients with colon cancer.


Condition Intervention Phase
Colon Neoplasm
Drug: CELECOXIB
Drug: CURCUMIN
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Curcumin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title: Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: March 2007
Detailed Description:

The primary end point of the study is time to tumor progression. The study is designed to detect increase in median time to tumor progression from 2.7 months to 4.0 months, with 80% power at a significance level of 5%. This requires approximately 100 patients. The median time to tumor progression of 2.7 months was found in the Investigational New Drug (IND) treatment program for gemcitabine, which enrolled 3023 patients with locally advanced or metastatic colon cance

  Eligibility

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

Inclusion Criteria:

3.1.1 Locally advanced or metastatic adenocarcinoma of the colon confirmed by histology or cytology.

3.1.2 Pateint who are qualified for treatment with gemcitabine 3.1.3 No prior chemotherapy for colon cancer. 3.1.4 Performance status 0-2 (ECOG scale). 3.1.5 Age ≥ 18 y. 3.1.6 Adequate hematologic function (ANC ≥ 1500/mm³, platelet count ≥ 100,000/mm³ ).

3.1.7 Adequate hepatic function (total bilirubin ≤ 2.0xUNL and AST, ALT and AP ≤ 5.0xUNL) 3.1.8 adequate renal function (creatinine ≤ 2.0). 3.1.9 Signed informed consent.

Exclusion Criteria:

3.2.1 A history of treated or active central nervous system involvement by the tumor or active neurological disease.

3.2.2 Prior radiation. Patients with disease outside the irradiation field or documented disease progression of previously irradiated disease are eligible.

3.2.3 Unstable medical condition, including uncontrolled diabetes mellitus or hypertension, active infection, unstable CHF, uncontrolled arrhythmias or unstable coagulation disorders.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295035

Contacts
Contact: Nadir Arber, Prof. 972-3-6974968 narber@post.tau.ac.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Arie Figer, MD Tel-Aviv Sourasky Medical Center
  More Information

Study ID Numbers: tasmc-05-na-05160-ctil
Study First Received: February 21, 2006
Last Updated: February 21, 2006
ClinicalTrials.gov Identifier: NCT00295035  
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Study placed in the following topic categories:
Curcumin
Celecoxib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Gemcitabine
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009