A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
1 other identifier
interventional
57
1 country
10
Brief Summary
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Jul 2001
Typical duration for phase_2 colorectal-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 24, 2002
CompletedFirst Posted
Study publicly available on registry
October 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedNovember 2, 2016
November 1, 2016
3.5 years
October 24, 2002
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor measurements (RECIST criteria)
Event driven
Secondary Outcomes (1)
Time to progression, time to response, duration of response, time to treatment failure, survival.\n
Event driven
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- locally advanced and/or metastatic colorectal cancer;
- \>=1 target lesion.
You may not qualify if:
- previous treatment with Xeloda or irinotecan;
- previous systemic therapy for metastatic disease;
- progressive disease during previous adjuvant therapy or within 6 months of completion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Hoover, Alabama, 35216, United States
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Miami, Florida, 33176, United States
Unknown Facility
Boston, Massachusetts, 02120, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
New York, New York, 10028, United States
Unknown Facility
Charlotte, North Carolina, 28233-3549, United States
Unknown Facility
Providence, Rhode Island, 02908, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Nashville, Tennessee, 37203-1632, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2002
First Posted
October 25, 2002
Study Start
July 1, 2001
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
November 2, 2016
Record last verified: 2016-11