Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT01303029
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Gemcitabine+erlotinib — DRUG
    Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .
  • Gemcitabine+erlotinib+capecitabine — DRUG
    Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .

Study Details

The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.

Key Dates

First listed
Feb 24, 2011
Start date
Feb 28, 2011
Status verified
Jul 2017
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Gemcitabine+erlotinib
  • Experimental: Experimental
    Gemcitabine+erlotinib+capecitabine

Primary Outcome Measure

Progression free survival [ Time Frame: 4 years ]

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