The Role of Epidermal Growth Factor Receptor (EGFR) and the Downstream Gene KRAS in Pancreatic Cancer Patients Receiving Gemcitabine Combined With Erlotinib Therapy
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Cancer
Both
Metastatic Pancreatic Cancer
Trial Information
The Role of Epidermal Growth Factor Receptor (EGFR) and the Downstream Gene KRAS in Pancreatic Cancer Patients Receiving Gemcitabine Combined With Erlotinib Therapy
The influence of EGFR and KRAS mutations on the efficacy of treatment with and without
erlotinib in metastatic pancreatic cancer is to be determined.
Inclusion Criteria:
- metastatic chemotherapy-naïve pancreatic cancer patients
- histologically confirmed
- adequate samples for analysis
- Karnofsky performance <= 2
- absolute neutrophil count (ANC) >= 1,500/mm3
- platelet count >= 100,000/mm3
- serum creatinine <= 1.5 mg/dL
- aspartate aminotransferase (AST)
- alanine aminotransferase (ALT) < 5 times the upper limit of normal
Exclusion Criteria:
- absence of any other malignancy or serious medical or psychological illness that
would preclude informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
one day
Safety Issue:
Yes
Principal Investigator
Chung-Pin Li, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Taipei Veterans General Hospital,Taiwan
Authority:
Taiwan: Department of Health
Study ID:
98-01-34A
NCT ID:
NCT01608841
Start Date:
July 2005
Completion Date:
July 2012
Related Keywords:
- Metastatic Pancreatic Cancer
- Pancreatic Neoplasms
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