Protocol No
HRI-AX-CL-PANC-PI-13301
Principal Investigator
Mandana Kamgar
Phase
II
Summary
The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and
gemcitabine given together are safe and effective. The combination of nab-paclitaxel plus
gemcitabine has been studied in treating patients with pancreatic cancer, and as of September
2013 is approved for the treatment of advanced pancreatic cancer. In this study, cisplatin will be
added to nab-paclitaxel plus gemcitabine and tested in people who have not yet had any cancer
therapy for the diagnosis of advanced pancreatic cancer, with the goal of improving response.
Another name for nab-paclitaxel is Abraxane®. Nab-paclitaxel contains the same medication as
the prescription chemotherapy drug Abraxane®. Nab-paclitaxel is approved by the FDA for the
treatment of advanced breast cancer, and in September 2013 nab-paclitaxel, combined with
gemcitabine, was approved by the FDA for the treatment of advanced pancreatic cancer.
Cisplatin is approved by the FDA for the treatment of advanced bladder cancer, advanced
ovarian cancer, and advanced testicular cancer and other childhood cancers. However, cisplatin
is not approved by the FDA for the treatment of advanced pancreatic cancer.
Gemcitabine was approved by the FDA in 1996 for the treatment of pancreatic cancer. It is also
an approved treatment for ovarian cancer, lung cancer, and breast cancer.
The Food and Drug Administration (FDA) has determined that this study meets the
requirements for Investigational New Drug (IND) Exemption.
Description
The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and
gemcitabine given together are safe and effective.
gemcitabine given together are safe and effective.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
ClinicalTrials.gov