Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
DRUGGemcitabine
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
DRUGErlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
DRUGOxaliplatin
Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed pancreatic cancer. * Measurable disease. * Absence of ascites or obstructive jaundice. * ECOG Performance Status 0-2. * Adequate liver kidney and bone marrow function. * Written informed consent.
Exclusion criteria
* Chronic diarrheic syndrome. * Uncontrolled brain metastases after radiation. * Liver infiltration over 50%. * Peripheral neuropathy ≥ 2. * No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix. * No active uncontrolled infection. * Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * Women who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 1 year survival |
Secondary
| Measure | Time frame |
|---|---|
| Progression free interval | 1 year |
| Response rate | Objective responses confirmed by CT or MRI on 3rd and 6th cycle |
| Toxicity profile | Toxicity assessment on each chemotherapy cycle |
| Symptoms improvement | Assessment every two cycles |
Countries
Greece
Outcome results
None listed