Status:
UNKNOWN
Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Colon Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 be...
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 signifi...
Eligibility Criteria
Inclusion
- 1.1 Locally advanced or metastatic adenocarcinoma of the colon confirmed by histology or cytology.
- 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 ).
- 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
- 2.1 A history of treated or active central nervous system involvement by the tumor or active neurological disease.
- 2.2 Prior radiation. Patients with disease outside the irradiation field or documented disease progression of previously irradiated disease are eligible.
- 2.3 Unstable medical condition, including uncontrolled diabetes mellitus or hypertension, active infection, unstable CHF, uncontrolled arrhythmias or unstable coagulation disorders.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00295035
Start Date
March 1 2006
End Date
March 1 2007
Last Update
February 22 2006
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