Trial information
A Study of Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Status: Completed
Protocol number: ML16832
Sponsor: Roche Korea Co Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Xeloda plus gemcitabine on tumor response in patients with locally advanced or metastatic pancreatic cancer
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenous gemcitabine in patients with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 62.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pancreatic Cancer
Primary outcome: 1. Overall objective response rate
Key secondary outcomes: 1. Efficacy: Duration of response, time to progression, time to response, time to treatment failure, and overall survival.
Safety: Adverse events and laboratory tests
Inclusion criteria:
- adult patients 18-75 years of age;
- locally advanced or metastatic pancreatic cancer.
Exclusion criteria:
- prior chemotherapy for pancreatic cancer;
- radiotherapy 4 weeks before treatment initiation;
- evidence of central nervous system metastases;
- history of another malignancy within last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix;
- history of lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
- clinically significant cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Korea, Republic of
