Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00564720
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
  • Gemcitabine — DRUG
    Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
  • Erlotinib — DRUG
    Erlotinib 100 mg by mouth (p.o.), daily until disease progression
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Study Details

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

Key Dates

First listed
Nov 28, 2007
Start date
Dec 31, 2006
Status verified
Feb 2013
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

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

Arms

  • Experimental: 1
    GEM/TAR
  • Experimental: 2
    GEM/OX/TAR

Primary Outcome Measure

Overall Survival [ Time Frame: 1 year survival ]

Related Studies