Previously untreated Patients with Colorectal Cancer and Advanced Liver Metastases. MedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Interventions
Trade Name: Vectibix
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Panitumumab
CAS Number: 339177-26-3
Current Sponsor code: ABX-EGF v03
Concentration unit: mg milligram(s)
Concentra
Sponsors
AZIENDA OSPEDALIERA ORDINE MAURIZIANO
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective response rate (ORR) over the entire treatment period when panitumumab is administered in combination with XELOX chemotherapy as 1st-line therapy in patients with previously untreated colorectal cancer and advanced liver metastases.;Secondary Objective: To assess the combination therapy of panitumumab plus XELOX chemotherapy on the percentage of patients whose disease becomes radically resectable, the time to resection and on the following efficacy measures: time to response, duration of response (DOR) progression free survival (PFS), overall survival (OS), time to relapse following surgery, time to progression (TTP), time to treatment failure (TtTF) and time to treatment discontinuation. To assess the safety of the combination therapy of panitumumab plus XELOX in patients with previously untreated metastatic colorectal cancer and advanced liver metastases;Primary end point(s): Objective Response Rate (ORR) over the entire treatment period (the proportion of subject?s in the ITT analysis set with a confirmed complete or partial response). Subject?s who do not respond will be considered a non-responder in the analysis. | — |
Countries
Italy
Outcome results
None listed