A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Anti-tumor response, thrombotic thrombocytopenic purpura (TTP), OS, duration of observed objective response [ Time Frame: every 6 weeks (end of every three courses) ] [ Designated as safety issue: Yes ]
- Quality of life (QOL) of the patients will be assessed utilizing Edmonton Assessment System [ Time Frame: At baseline and the end of each cycle ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
escalating doses of capecitabine from 1000 mg/m2 BID, 1250 mg/m2 BID, 1500 mg/m2 BID, to 1750 mg/m2 BID (days 1 through 7).
Other Name: XelodaDrug: PHY906
PHY906 800 mg BID (days 1 through 4)
Other Name: Traditional Chinese Medicine: Scutellaria baicalensis Georgi, Glycyrrhiza uralensis Fisch., Ziziphus jujuba Mill., and Paeonia lactiflora Pall
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411762
|United States, Connecticut|
|Yale Comprehensive Cancer Center at Yale University School of Medicine|
|New Haven, Connecticut, United States, 06519|
|Study Chair:||Wasif M Saif, MD||Yale University|