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Sponsors and Collaborators: |
Yale University PhytoCeutica National Comprehensive Cancer Network Hoffmann-La Roche |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00411762 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Capecitabine Drug: PHY906 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 48 |
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) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Capecitabine
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).
Drug: PHY906
PHY906 800 mg BID (days 1 through 4)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with adequate hepatic function defined as
(Calculated by Cockcroft-Gault equation).
Patients with adequate hematologic tests:
Exclusion Criteria:
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 |
Responsible Party: | Yale University School of Medicine ( Wasif Saif, M.D. Principal Investigator ) |
Study ID Numbers: | 0512000905 |
Study First Received: | December 13, 2006 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00411762 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreatic |
Antimetabolites Capecitabine Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms Carcinoma |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |