The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• metastatic chemotherapy-naïve pancreatic cancer patients

• histologically confirmed

• adequate samples for analysis

• Eastern Cooperative Oncology Group (ECOG) performance status <= 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