Overview

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