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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupoli, Greece
Air Forces Military Hospital of Athens
Athens, Greece
Errikos Ntynan General Hospital
Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology
Overall Survival
Time frame: 1 year survival
Progression free interval
Time frame: 1 year
Response rate
Time frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Symptoms improvement
Time frame: Assessment every two cycles
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Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens, Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Athens, Greece
State General Hospital of Larissa
Larissa, Greece
Diabalkaniko General Hospital of Thessaloniki
Thessaloniki, Greece