Patients with unresectable liver metastases of colorectal cancer who previously failed pretreatment with 5FU/oxaliplatin and/or 5FU/irinotecan (2nd- or 3rd-line). MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Campto
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: IRINOTECAN
CAS Number: 97682445
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Martin Luther Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k-ras wild-type tumours 2) Patients had been treated and shown to be refractory to 5-FU (Capecitabine allowed)/oxaliplatin and/or 5-FU/irinotecan. Prior therapy with VEGF-inhibitors (e.g bevacizumab) is allowed 3) Patients with at least one measurable liver metastasis, with size > 1cm (RECIST criteria) 4) Patients with liver only or liver dominant disease (defined as = 50 % tumour burden confined to the liver) 5) Patients with a portal vein not interfering with transarterial chemoembolization (e.g. no thrombosis) as judged by the investigator 6) ECOG Performance status = 2 7) Life expectancy > 3 months 8) Age = 18 years. 9) At least 4 weeks since last administration of last chemotherapy and/or radiotherapy (bone metastases may be allowed) 10) Patients who received VEGF-inhibition (e.g. with bevacizumab) in prior therapy are eligible if stopped since 4-6 weeks before randomization 11) Haematologic function: ANC = 1.5 x 109/L, platelets = 75 x109/L 12) INR =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1) Presence of CNS metastases 2) Contradindications to irinotecan therapy (Chronic inflammatory bowel disease and/or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate) 3) Active bacterial, viral or fungal infection within 72 hours of study entry 4) Women who are pregnant or breast feeding 5) Allergy to contrast media 6) Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix 7) Any contraindication for hepatic embolisation procedures: • Large shunt as determined by the investigator (pretesting with lung perfusion scan not required) • Severe atheromatosis • Hepatofugal blood flow 8) Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation 9) Known hypersensitivity or contraindication to the drugs used in the trial (eg: cetuximab, 5-HT3 receptor antagonist, dexamethasone, or any component of aprepitant)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of acute and delayed emesis during chemoembolization with or without aprepitant ;Timepoint(s) of evaluation of this end point: the last visit of the last subject undergoing the trial | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer.;Secondary Objective: Secondary objectives are safety and tolerability of hepatic chemoembolization. ;Primary end point(s): Progression free survival rate after 6 months;Timepoint(s) of evaluation of this end point: the last visit of the last subject undergoing the trial | — |
Countries
Germany
Contacts
Public ContactStudienkoordination
Koordinierungszentrum für Klinische Studien
Outcome results
None listed