S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression, KRAS mutation, and BRAF mutation as predictive or prognostic markers

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

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborator: Jeil Pharmaceutical Co., Ltd.
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system)

• Measurable or evaluable disease by RECIST criteria 1.1

• Minimum age of 18 years

• ECOG Performance status 0-1

• Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy.

• More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)

• Adequate organ functions

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

• Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy.

• Patients with CNS metastases

• Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding

• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

• Known history of cerebral or leptomeningeal metastases or neurologic disease