Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations

Sponsor
Vejle Hospital
Study ID
NCT01206049
Phase
PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1,000 mg/m2 on day 1 of a 2 weeks cycle
  • Oxaliplatin — DRUG
    60 mg/m2 on day 1 of a 2 weeks cycle
  • Capecitabine — DRUG
    1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
  • Panitumumab — DRUG
    6 mg/kg on day 1 of a 2 weeks cycle
  • Bevacizumab — DRUG
    10 mg/kg on day 1 of a 2 weeks cycle

Study Details

The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.

Key Dates

First listed
Sep 21, 2010
Start date
Sep 30, 2010
Status verified
Jun 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Combination chemotherapy + panitumumab
  • Experimental: Combination chemotherapy + bevacizumab

Primary Outcome Measure

The fraction of patients alive and without progression at 6 months [ Time Frame: 6 months from enrollment date ]

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