Metastatic colorectal cancer MedDRA version: 17.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: MOC31-PE
Pharmaceutical Form: Concentrate for solution for injection/infusion
Current Sponsor code: MOC31-PE
Other descriptive name: Monoclonal antibody conjugated pseudomonas exotoxin
C
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically verified EpCAM positive peritoneal carcinomatosis from colorectal cancer - Ambulatory with ECOG performance status 0-1 at the time of surgery - At least 18 years of age - Isolated PC upon radiological work-up. - Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure - PCI =20 - Laboratory values: - ANC >= 1.5 x 109/L - Platelets >= 100 x 109/L - Hb >= 9g/dL - Creatinine 30 g/L - INR=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected. - History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer. - History of CNS or bone metastases - Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia - Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment - BMI > 35 - Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and toxicity (Dose Limiting Toxicity) after intraperitoneal administration of MOC31PE.;Secondary Objective: - Overall survival - Progression free survival. - Determine pharmacokinetics and neutralizing anti-immunotoxin antibody response upon intraperitoneal administration of MOC31PE after CRS and HIPEC. - Identify biomarkers of disease recurrence (genomic and proteomic analysis of tumor tissue, normal blood cells and serum/plasma).;Primary end point(s): 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 status will also be assessed.;Timepoint(s) of evaluation of this end point: Safety profile will be evaluated at each visit. Patient will be hospitalized during 9 days after treatment. Patient will come as outpatient during week 4 and 8 and therafter every 3 months up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival - Progression free survival - Determine pharmacokinetics and neutralizing anti-immunotoxin antibody response upon intraperitoneal administration of MOC31PE after CRS and HIPEC - Identify biomarkers of disease recurrence (genomic and proteomic analysis of tumor tissue, normal blood cells and serum/plasma).;Timepoint(s) of evaluation of this end point: - up to 5 years after treatment - Every 3 months and up to 5 years - Pharmacokinetic monitoring for 48 hours after MOC31PE administration. Measurement of antibody formation 4 and 8 weeks posttreatment. Serum samples will be collected at 0 h, 3 h, 6 h, 12 h, 24 h, 48 h and at 4 weeks and 8 weeks. - Samples (blood and tissues) collected on day 1 (prior treatment) | — |
Countries
Norway
Contacts
Public ContactSvein Dueland
Oslo University hospital
Outcome results
None listed