Metronomic chemiotherapic treatment WITH IRINOTECAN Cpt-11 IN PATIENTS WITH metastatic colon-rectal cancer PHARMACODYNAMIC And PHARMACOKINETIC evaluation. - CPTTS Study

• Conditions: Colonrectal metatstatic cancer; MedDRA version: 6.1Level: PTClassification code 10052358

• Registration Number: EUCTR2006-001045-34-IT
• Lead Sponsor: AZIENDA USL 6 LIVORNO ZONA LIVORNESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Age 18 years ECOG PS to 2 istologic Diagnoses of colorectal cancer with not resecabile metastatic disease Previous comprising treatments for the metastatic disease Cpt-11, L-ohp and 5-fu/lv or contraindication to theirs I use measurable or valued Disease Attended of life at least 3 months Adapted renal functionality creatinine 1,25 V.N. Adapted hepatic functionality bil. tot. 1,5 V.N., PAL 2,5 V.N., SGOT and SGPT 5 V.N. Adapted medullary functionality GB 3000 x 109/L, PLT 100,000 x 109/L, Hgb 10 g/dL informed Consent written Last finished chemioterapic or radioterapic treatment from at least 4 weeks
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Encefalic metastases Crohn disease, other inflammatory disease of the intestine Colectomia total or ileostomia Occlusion or internal sub-occlusion scompensate metabolic Diseases or infections in action cardiac Arrhythmies or ischemic cardiopathy not controlled Impossibility to execute adequate follow-up a Pregnancy upgrades them or in action Breast-feeding Second neoplasma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation the feasibility and the optimal dose of a metronomic treatment with Cpt-11 in continuous infusion. For metronomic optimal dose of Cpt-11 that dose of Cpt-11 in a position to developing one biological activity of antiangiogenetic type will agree without to cause important toxicities.;Secondary Objective: To describe to the farmacocinetic profiles of the metronomic treatment with Cpt-11, estimating the main kinetic parameters of the Cpt-11 . To determine the antitumor activity of the treatment. To estimate correlations between dose of Cpt-11, farmacocinetic parameters, biological and clinical activity;Primary end point(s): Evaluation the toxicity tied to the treatment and in order to execute the withdrawals of blood us for the appraisal pharmacokinetic and farmacodinamic