Metastatic Pancreatic Cancer
Conditions
Keywords
Gemcitabine, Cisplatin, Erlotinib
Brief summary
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
Interventions
DRUGGemcitabine, Cisplatin, Erlotinib (Tarceva)
* Erlotinib 100 mg po q d daily AND * Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8 * Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8 Every 3 weeks
Sponsors
Dong-A University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Gyeongsang National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age older than 18 * Younger than 75 * ECOG performance status 0 or 1 * Histologically confirmed adenocarcinoma of the pancreas * Metastatic pancreatic cancer * No prior chemotherapy for metastatic pancreatic cancer * A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
Exclusion criteria
* A patient with no measurable disease * A patient who received previous palliative chemotherapy for pancreatic cancer * A patient with locally advanced pancreatic cancer * A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year * A patient with previous active or passive immunotherapy * A pregnant or lactating patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer | Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan |
Countries
South Korea
Outcome results
None listed