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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01608841

98-01-34A

Details and patient eligibility

About

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.

Full description

The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Gemcitabine

No Intervention group

Gemcitabine plus erlotinib

Experimental group

Treatment:

Drug: Erlotinib