A Phase II Randomized Clinical Trial of Panitumumab plus Gemcitabine and Oxaliplatin (GEMOX) versus GEMOX alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma - Vecti-BI

• Conditions: advanced intrahepatic colangiocarcinoma and extrahepatic biliary adenocarcinoma including gallbladder; MedDRA version: 9.1Level: LLTClassification code 10008594; MedDRA version: 9.1Level: LLTClassification code 10025943; MedDRA version: 9.1Level: LLTClassification code 10061239; MedDRA version: 9.1Level: LLTClassification code 10022789

• Registration Number: EUCTR2009-017428-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ORDINE MAURIZIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-19
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

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

Inclusion Criteria

? Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild-type); ? Documented KRAS status either on primary tumor or metastasis. ? ECOG PS of 0, 1 or 2 ? Extimated life expectancy of at least 3 months. ? Adequate bone marrow, hepatic, and renal function
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

? Any previous chemotherapy or target therapy. ? Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. ? Coexisting malignancies, except for basal or squamous cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type).;Secondary Objective: To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.;Primary end point(s): Progression-free survival (PFS), defined as the time from randomization to evidence of progression, death, or last radiographic assessment in absence of a PFS event.