J11125 Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in combination with Cisplatin in Subjects with Metastatic Pancreatic Cancer
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 months.
Inclusion Criteria *Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed histology will be excluded. *Patient not have had any chemotherapy must have completed chemotherapy greater than 5 years prior to enrollment.
This study is a single arm phase II study to assess the efficacy of the combination of GTX and cisplatin in subjects with metastatic pancreatic cancer. Treatment will be administered on an outpatient basis. One cycle is 21 days. Xeloda will be taken orally on days 1-14; Gemcitabine, Taxotere, Cisplatin will be given on days 4 an 11.
05/21/2013 04:02 AM