Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Generic Devices Consulting, Inc.
• Collaborator: Biocompatibles UK Ltd
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Patients with confirmed diagnosis of stage IV colorectal cancer with unresectable liver metastases (primary tumor may be present)

• Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)

• Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver

• Patients with patent main portal vein

• Performance status ≤ 2 ECOG

• Life expectancy > 6 months

• Aged ≥18 years

• Patient has failed (discontinued for progression or toxicity) one prior line of chemotherapy for metastatic disease, preferably oxaliplatin-based (e.g. FOLFOX, CAPOX). Note that substitutions of oral versus IV 5-FU formulations, changes in 5-FU schedules, or discontinuations/re-starting of the same chemotherapy drugs will not be considered as separate lines of therapy, nor will the addition of "biologics" such as bevacizumab, cetuximab, or panitumumab

• Patient has no previous treatment with irinotecan

• At least 4 weeks since last administration of last chemotherapy and /or radiotherapy

• Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥75 x10-9/L, INR <1.5 (patients on therapeutic anticoagulants are not eligible)

• Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl,

• Adequate renal function (creatinine ≤ 2.0mg/dl)

• Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG/urine test for women of child-bearing age)

• Signed, written informed consent

Exclusion Criteria:

• Patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor <5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl

• Contraindications to irinotecan:

• Chronic inflammatory bowel disease and/or bowel obstruction

• History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate, lactic acid or to any of the excipients of Camptosar

• Severe bone marrow failure

• History of Gilbert Syndrome (specific testing not required)

• Concomitant use with St John's Wort (Hypericum)

• Active bacterial, viral or fungal infection within 72 hours of study entry

• Women who are pregnant or breast feeding

• Previous irinotecan based therapy for metastatic disease

• Patients' whose only measurable disease is within an area of the liver previously subject to radiotherapy

• Allergy to contrast media that cannot be managed with standard care (e.g. steroids)

• Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin

• Contraindicated for MRI or CT

• Patients previously treated with transarterial embolization (with or without chemotherapy)

• Any contraindication for hepatic embolization procedures:

• Large shunt as determined by the investigator (pretesting with TcMMA not required)

• Severe atheromatosis

• Hepatofugal blood flow

• Main portal vein occlusion (e.g. thrombus or tumor)

• 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