Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Time to Progression

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

62202-788

NCT ID:

NCT00747097

Start Date:

September 2008

Completion Date:

September 2010

Related Keywords:

  • Time to Progression
  • Biliary Tract Neoplasms

Name

Location