E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colonrectal metatstatic cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |