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A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma

NCT00411762 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-03-27

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Capecitabine

DRUG

PHY906

Sponsors & Collaborators

Principal Investigators

  • Howard Hochester, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00411762 on ClinicalTrials.gov