- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048139
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
November 1, 2016 updated by: Hoffmann-La Roche
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Arizona
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Phoenix, Arizona, United States, 85012
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California
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Fountain Valley, California, United States, 92708
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La Jolla, California, United States, 92037-1030
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Santa Rosa, California, United States, 95403
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Colorado
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Denver, Colorado, United States, 80262
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-
Kansas
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Hutchinson, Kansas, United States, 67502
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Nevada
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Las Vegas, Nevada, United States, 89109
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-
New Mexico
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Albuquerque, New Mexico, United States, 87102
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Albuquerque, New Mexico, United States, 87131-5636
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New York
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Buffalo, New York, United States, 14263
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Texas
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Houston, Texas, United States, 77030
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients >=18 years of age;
- locally advanced and/or metastatic colorectal cancer;
- >=1 target lesion.
Exclusion Criteria:
- previous treatment with Xeloda or irinotecan;
- previous systemic therapy for metastatic disease;
- progressive disease during previous adjuvant therapy or within 6 months of completion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
250mg/m2 iv on day 1 of each 3 week cycle
1000mg/m2 po bid on days 1-15 of each 3 week cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor measurement (RECIST criteria)
Time Frame: Event driven
|
Event driven
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.
Time Frame: Event driven
|
Event driven
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
October 24, 2002
First Submitted That Met QC Criteria
October 24, 2002
First Posted (Estimate)
October 25, 2002
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Irinotecan
Other Study ID Numbers
- MO16461
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
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-
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-
Centre Oscar LambretSFCECompleted
-
Boston Scientific CorporationBiocompatibles UK LtdCompletedMetastatic Colorectal CancerUnited Kingdom, Austria, France
-
Nelson YeeIpsenActive, not recruitingLocally Advanced Pancreatic Carcinoma(LAPC)United States
-
Fudan UniversityNot yet recruitingSmall Cell Lung Cancer RecurrentChina
-
University of California, IrvineWithdrawnMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | Central Nervous System Metastases
-
Dong-A University HospitalPusan National University Yangsan HospitalCompletedGastric CancerKorea, Republic of
-
Bristol-Myers SquibbCompleted