Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Primary Objectives
To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with
cisplatin in subjects with metastatic pancreatic cancer based on the progression-free
survival (PFS) rate at 6 month.
Secondary Objectives
- To assess safety and characterize toxicities of the combination of GTX with cisplatin in
subjects with metastatic pancreatic cancer.
- To estimate disease control rate (DCR), PFS, and overall survival (OS).
- To estimate a PFS rate of an expansion cohort testing an alternative schedule.
Study Design
This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in
subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be
enrolled, 28 in the initial cohort and 10 in the expansion cohort
The study will have a safety run-in phase consisting of 6 subjects. To ensure that the
combination is safe, the first six subjects will be treated at DL1 and observed for limiting
toxicity for the first 2 cycles before continuation with further accrual. After the safety
run-in, the study will be continuously monitored for adverse events.
The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of
subjects alive, free of disease progression at 6 months. The treatment regimen would be
considered of insufficient activity for further study in this population if PFS rate at 6
months is 50% or less, and the minimum required level of efficacy that would warrant further
study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes
interim monitoring for futility using a predictive probability approach. We will stop the
study early if given the information at the interim analysis, it is unlikely that the PFS
rate at 6 months will be greater than 50% if the study continues to the end.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins