Phase I/II study of prevention of Colorectal Cancer CRC with Allopurinol in High-Risk Subjects - APAC

Conditions: CHEMOPREVENTION OF COLORECTAL CANCER
MedDRA version: 9.1Level: LLTClassification code 10048832Term: Colon adenoma

Registration Number: EUCTR2006-001084-27-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI GALLIERA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 75

Inclusion Criteria

1.Age 8805; 18 years, 75 years; 2.Provision of written informed consent; 3.Subjects with one ore more colorectal adenomatous polyps diam. 8805; 1 cm ; 4.Adequate renal and hepatic function; 5.Performance status 8804; 1;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of iperplastic polyps and/or flat adenomas; Subjects with pre-existing CCR; Presence of carcinoma tissue in adenoma; Previous allopurinol assumption within 6 months ; Pregnancy or breast feeding women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment ; Known severe hypersensitivity to allopurinol or any of the excipients of this product; Geographic inaccessibility or proven difficulty to assure adequate compliance; Renal failure grade 1 creatinine 1.5 x ULN ; Acute Gout; Subjects in anticoagulant therapy with dicumarol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67;Secondary Objective: Secondary objectives are to investigate the effects of allopurinol on potential biomarkers measured as a change from the baseline Bcl-2, COX-2, topoisomerase-II-a as a measure of apoptosis, IGF-I, IGFBP-3 and IGF-I/IGFBP-3 inflammation indexes u-PCR We will also evaluate the safety and tolerability of the two different scheduled doses of 100mg and 300mg /day of allopurinol.;Primary end point(s): The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67, a biomarker of cell proliferation, in CRC tissue at baseline tumor or polyp biopsy and after 4 weeks of allopurinol treatment surgical resection specimen .

Secondary Outcome Measures