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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cetuximab; Gemcitabine

Criteria

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