An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01399190
First received: July 20, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with Xeloda (capecitabine) and oxaliplatin as first-line treatment in patients with colorectal cancer. Data will be collected from each patient until disease progression occurs (for up to 30 months).
| Condition |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate (tumour assessments according to RECIST criteria) [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with colorectal cancer on first-line treatment with Avastin in combination with Xeloda and oxaliplatin
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Treatment in accordance with current Summary of Product Characteristics and local guidelines
Exclusion Criteria:
- Contraindications according to current Summary of Product Characteristics and local guidelines
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399190
Contacts
| Contact: Please reference Study ID Number: ML25523 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Slovakia | |
| Recruiting | |
| Banska Bystrica, Slovakia, 975 17 | |
| Active, not recruiting | |
| Bratislava, Slovakia, 812 50 | |
| Active, not recruiting | |
| Bratislava, Slovakia, 833 10 | |
| Active, not recruiting | |
| Kosice, Slovakia, 04191 | |
| Active, not recruiting | |
| Martin, Slovakia, 036 59 | |
| Active, not recruiting | |
| Nitra, Slovakia, 950 01 | |
| Active, not recruiting | |
| Poprad, Slovakia, 058 01 | |
| Active, not recruiting | |
| Presov, Slovakia, 081 81 | |
| Active, not recruiting | |
| Ruzomberok, Slovakia, 03426 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01399190 History of Changes |
| Other Study ID Numbers: | ML25523 |
| Study First Received: | July 20, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Slovakia: State Institute for the Control of Drugs |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Capecitabine |
Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013