OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00577031
First received: December 18, 2007
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: bevacizumab [Avastin] Drug: Oxaliplatin Drug: Xeloda |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Efficacy and Safety Study of Bevacizumab (Avastin®) in Combination With XELOX (Oxaliplatin Plus Xeloda®) for the First-line Treatment of Patients With Metastatic Cancer of the Colon or Rectum - 'OBELIX' |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate, time to response, duration of response, overall survival rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
7.5mg iv on day 1 of each 3 week cycle
Drug: Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle
Drug: Xeloda
1000mg/m2 po bid on days 1-14 of each 3 week cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- locally advanced or metastatic colorectal cancer;
- no previous treatment with chemotherapy for metastatic disease;
- at least one measurable lesion.
Exclusion Criteria:
- radiotherapy to any site within 4 weeks before study;
- untreated brain metastases or primary brain tumors;
- clinically significant cardiovascular disease;
- chronic daily treatment with high dose aspirin (>325 mg/day);
- other co-existing malignancies or malignancies diagnosed within last 5 years.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577031
Locations
| Italy | |
| Bologna, Italy, 40138 | |
| Brescia, Italy, 25122 | |
| Cagliari, Italy, 09121 | |
| Cagliari, Italy, 09100 | |
| Caserta, Italy, 81100 | |
| Catanzaro, Italy, 88100 | |
| Cefalu, Italy, 90015 | |
| Fano, Italy, 61032 | |
| Firenze, Italy, 50139 | |
| Frattaminore, Italy, 80026 | |
| Grosseto, Italy, 58100 | |
| Ivrea, Italy, 10015 | |
| Latisana, Italy, 33053 | |
| Lecce, Italy, 73100 | |
| Legnago, Italy, 37045 | |
| Legnano, Italy, 20025 | |
| Macerata, Italy, 62100 | |
| Napoli, Italy, 80131 | |
| Negrar, Italy, 37024 | |
| Orbassano, Italy, 10043 | |
| Padova, Italy, 35128 | |
| Palermo, Italy, 90146 | |
| Palermo, Italy, 90127 | |
| Pavia, Italy, 27100 | |
| Reggio Calabria, Italy, 89100 | |
| Reggio Emilia, Italy, 42100 | |
| Rionero in Vulture, Italy, 85028 | |
| Roma, Italy, 00189 | |
| Roma, Italy, 00184 | |
| Roma, Italy, 00152 | |
| Roma, Italy, 00186 | |
| Salerno, Italy, 84131 | |
| San Giovanni Rotondo, Italy, 71013 | |
| Sondrio, Italy, 23100 | |
| Taormina, Italy, 98039 | |
| Torino, Italy, 10153 | |
| Torino, Italy, 10125 | |
| Verbania, Italy, 28921 | |
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: | NCT00577031 History of Changes |
| Other Study ID Numbers: | ML21380 |
| Study First Received: | December 18, 2007 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
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 16, 2013