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Phase I/II study of immuntoxin for treatment of metastatic abdominaldisease in patient with colorectal cancer.

ABSTRACT: Primary objectives: To assess safety and toxicity (Dose Limiting Toxicity) after intraperitoneal administration of MOC31PE. Primary endpoints: Frequency and severity of adverse events and serious adverse events.The NCI Common Terminology Criteria for Adverse Events Version 4.0(CTCAE) will be used.Changes in laboratory values, vital signs and ECOG performance statuswill also be assessed.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Cancer Metastatic

PROVIDER: 2531813 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Primary objectives: ?To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer.?To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy.?To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy.?To explore the incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.?To explore the incidence of adverse events by severity, of serious adverse events, of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity.?To assess E-52862 plasma exposure associated with the treatment. Primary endpoints: Efficacy endpoints:-Evolution of the clinical Total Neuropathy Score (cTNS).-Change from baseline of the reduced Total Neuropathy Score (rTNS).-Evolution of cold-induced pain intensity.-Change from baseline of the number and duration of signs and symptoms of OXL-induced acute neuropathy assessed with the specific OXL-induced neuropathy questionnaire.-Level of peripheral sensory neuropathy toxicity at each visit assessed with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria.-Time to the first occurrence of NCI-CTCAE grade 2, 3 or 4 symptomatic neuropathy.-Change from baseline of the amplitudes of sensory and motor nerve action potentials and of the sensitive and motor nerve conduction velocities measured in the nerve conduction tests.-Evolution of patients’s quality of life assessed with the Quality of Life Questionnaire C30 (QLQ-C30) with the module for chemotherapy-induced neuropathy (QLQ-CIPN20).-Proportion of patients who meet any of the following definitions of neuropathy at the end of the study: a) at least subclinical neuropathy: cTNS >2, b) manifest neuropathy: rTNS > or equal 5, c) symptomatic neuropathy: grade >1 NCI-CTCAE toxicity, and d) severe neuropathy: grade > or =3 NCI-CTCAE toxicity.-Incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.-Total cumulative dose of OXL administered. Safety endpoitns:-Incidence of adverse events by severity, of serious adverse events, of adverse events leading to E-52862 discontinuation and of adverse events related to E-52862 by severity. Values for these variables will be obtained in all visits of the study, except in the screening visit.-E-52862 plasma concentration associated with the treatment.

Dataset Information

Phase I/II study of immuntoxin for treatment of metastatic abdominaldisease in patient with colorectal cancer.

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