Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: February 21, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00295035

Contact: Nadir Arber, Prof. 972-3-6974968

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Arie Figer, MD Tel-Aviv Sourasky Medical Center
  More Information Identifier: NCT00295035     History of Changes
Other Study ID Numbers: tasmc-05-na-05160-ctil 
Study First Received: February 21, 2006
Last Updated: February 21, 2006
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 30, 2016