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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00747097

Acronym

ECHO

Enrollment

Registered

2008-09-04

Start date

2008-09-30

Completion date

2010-09-30

Last updated

2011-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Time to Progression

Brief summary

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.

Interventions

DRUGgemcitabine + 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	6 months

Secondary

Measure	Time frame
overall survival, objective response, safety	12 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026