A Phase II Clinical Trial of Panitumumab in Combination with Infusional Oxaliplatin and Oral Capecitabine (XELOX) Chemotherapy as 1st line Therapy in Patients with Colorectal Cancer and Advanced Liver Metastases - ND

• Conditions: Previously untreated Patients with Colorectal Cancer and Advanced Liver Metastases.; MedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic

• Registration Number: EUCTR2007-002007-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ORDINE MAURIZIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven colorectal adenocarcinoma Stage IV disease, with liver involvement ± regional lymphonodes Number and extent of hepatic metastases: - > 3 liver metastases - > 50% hepatic involvement requiring a major hepatectomy with controlateral wedge resection - Any metastases requiring a resection not fulfilling the following criteria: (1) the ability to preserve two contiguous hepatic segments, (2)preservation of adequate vascular inflow and outflow as well as biliary drainage, and (3) the ability to preserve adequate future liver remnant No previous chemotherapy No previous radiotherapy ECOG Performance status < or = 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other primary solid tumor treated less then 5 years prior to enrollment Adenocarcinoma of the middle and /or lower rectum (within 12 cm from the anal verge) Extrahepatic metastasis, other than regional lymph nodes Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified