This protocol is part of a larger grant funded by the NCI to create an international research
center to study traditional Chinese medicine (TCM). All of the patients enrolled in this
study will be treated at the Cancer Hospital, Fudan University, our sister institution in
Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the
Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance
through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The
research nurses have received training at MDACC and will receive regular oversight by MDACC
personnel.
Primary End Point:
1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.
Secondary End Points:
1. Examine the feasibility and safety of treatment using huachansu in combination with
gemcitabine in patients with pancreatic cancer.
2. Determine clinical efficacy by other measures including tumor response, 6-month
survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
3. Monitor patient blood levels of the three main cardiac glycosides that are in huachansu
(bufalin, cinobufagin, and resibufogenin). This information will provide evidence to
delineate the role of these cardiac glycosides in antitumor activity.