A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Phase 2
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Metastatic Pancreatic Cancer
Both
Metastatic Pancreatic Cancer
Trial Information
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
Outcome Time Frame:
Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
Safety Issue:
Yes
Authority:
South Korea: Institutional Review Board
Study ID:
Gyeongsang-001
NCT ID:
NCT00922896
Start Date:
June 2009
Completion Date:
May 2011
Related Keywords:
- Metastatic Pancreatic Cancer
- Gemcitabine
- Cisplatin
- Erlotinib
- Pancreatic Neoplasms
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