S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

Sponsor
Hallym University Medical Center
Study ID
NCT01693419
Phase
PHASE2
Status
Completed

Conditions

  • Pancreas Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GES (Gemcitabine, Erlotinib, S-1) — DRUG
    Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14

Study Details

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

Key Dates

Start date
Aug 31, 2011
Status verified
Aug 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GES (Gemcitabine, Erlotinib, S-1)
    Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14

Primary Outcome Measure

Objective response rate [ Time Frame: 1.5 years ]

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