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

Phase 3
18 Years
Not Enrolling
Colon Neoplasm

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Trial Information

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

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

Inclusion Criteria:

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Arie Figer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel-Aviv Sourasky Medical Center


Israel: The Israel National Institute for Health Policy Research and Health Services Research

Study ID:




Start Date:

March 2006

Completion Date:

March 2007

Related Keywords:

  • Colon Neoplasm
  • Neoplasms
  • Colonic Neoplasms