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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001045-34-IT

Enrollment

Registered

2006-03-14

Start date

2005-04-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonrectal metatstatic cancer MedDRA version: 6.1 Level: PT Classification code 10052358

Interventions

Trade Name: CAMPTO 1 FL 40 MG/2ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Irinotecan CAS Number: 136572-09-3 Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026