Pancreatic Cancer Clinical Trial
Official title:
A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
The aim of this research project is to determine the amount of capecitabine (Xeloda) which
can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the
aim of this research project to determine what the effects, good and/or bad, are of
combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of
advanced pancreatic cancer.
PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906
has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for
hundreds of years.
The other drug involved in this study, capecitabine is an oral form of chemotherapy already
approved by FDA in the management of colorectal and breast cancer.
Laboratory studies in animal models have shown that the combination of capecitabine and
PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this
combination in patients with liver cancer to define the benefit. PHY906 has also shown to
decrease diarrhea related to chemotherapy in a small study performed in patients with colon
cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that
the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models.
This prompted us to test the combination of capecitabine and PHY906 in patients with
advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side
effects, such as diarrhea caused by capecitabine.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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