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

Time to Progression Clinical Trial

— ECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747097
• Other study ID #: 62202-788
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2008
• Last updated: February 9, 2011
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: February 2011
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Time to Progression

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St.-Luc	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		6 months	Yes
Secondary	overall survival, objective response, safety		12 months	Yes