Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

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Detailed Description

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Conditions

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Time to Progression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

gemcitabine+cetuximab

Group Type EXPERIMENTAL

gemcitabine + cetuximab

Intervention Type DRUG

gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment

Interventions

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gemcitabine + cetuximab

gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
* signed written informed consent
* age \> 18
* WHO PS 0 or 1 at study entry
* measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
* adequate renal (serum creatinin\<1.5x upper reference range), liver (total bilirubin\<2x upper reference range) and hematopoietic functions (PMN\>1,5x109/L, platelets\>100x109/L)
* life expectancy of at least 12 weeks
* effective contraception throughout the study for both male and female patients if the risk of conception exists

Exclusion Criteria

* uncontrolled concurrent CNS, cardiac, infectious diseases
* previous exposure to epidermal growth factor targeting therapy
* known hypersensitivity to any components of study treatments
* previous chemotherapy for this cancer
* previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
* pregnancy or breast feeding
* medical or psychological conditions that would not permit the patient to complete the study or sign informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No