OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
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'
1 other identifier
interventional
205
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 colorectal-cancer
Started Feb 2008
Typical duration for phase_4 colorectal-cancer
38 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
First Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
August 18, 2015
CompletedAugust 18, 2015
July 1, 2015
3.5 years
December 18, 2007
July 15, 2014
July 21, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Baseline and Day 1 of every cycle until disease progression or death up to 5 years
PFS: Time to Event
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.
Baseline and Day 1 of every cycle until disease progression or death up to 5 years
Secondary Outcomes (14)
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment
Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
Percentage of Participants With a CR or PR Among Participants in the ITT Population
Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
Time to CR or PR Overall Response - Time to Event
Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment
Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event
Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
- +9 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Brescia, 25122, Italy
Unknown Facility
Cagliari, 09100, Italy
Unknown Facility
Cagliari, 09121, Italy
Unknown Facility
Caserta, 81100, Italy
Unknown Facility
Catanzaro, 88100, Italy
Unknown Facility
Cefalù, 90015, Italy
Unknown Facility
Fano, 61032, Italy
Unknown Facility
Florence, 50139, Italy
Unknown Facility
Frattaminore, 80026, Italy
Unknown Facility
Grosseto, 58100, Italy
Unknown Facility
Ivrea, 10015, Italy
Unknown Facility
Latisana, 33053, Italy
Unknown Facility
Lecce, 73100, Italy
Unknown Facility
Legnago, 37045, Italy
Unknown Facility
Legnano, 20025, Italy
Unknown Facility
Macerata, 62100, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Negrar, 37024, Italy
Unknown Facility
Orbassano, 10043, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Palermo, 90127, Italy
Unknown Facility
Palermo, 90146, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Reggio Calabria, 89100, Italy
Unknown Facility
Reggio Emilia, 42100, Italy
Unknown Facility
Rionero in Vulture, 85028, Italy
Unknown Facility
Roma, 00152, Italy
Unknown Facility
Roma, 00184, Italy
Unknown Facility
Roma, 00186, Italy
Unknown Facility
Roma, 00189, Italy
Unknown Facility
Salerno, 84131, Italy
Unknown Facility
San Giovanni Rotondo, 71013, Italy
Unknown Facility
Sondrio, 23100, Italy
Unknown Facility
Taormina, 98030, Italy
Unknown Facility
Torino, 10125, Italy
Unknown Facility
Torino, 10153, Italy
Unknown Facility
Verbania, 28921, Italy
Related Publications (1)
Antonuzzo L, Giommoni E, Pastorelli D, Latiano T, Pavese I, Azzarello D, Aieta M, Pastina I, Di Fabio F, Bertolini A, Corsi DC, Mogavero S, Angelini V, Pazzagli M, Di Costanzo F. Bevacizumab plus XELOX as first-line treatment of metastatic colorectal cancer: The OBELIX study. World J Gastroenterol. 2015 Jun 21;21(23):7281-8. doi: 10.3748/wjg.v21.i23.7281.
PMID: 26109816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 19, 2007
Study Start
February 1, 2008
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 18, 2015
Results First Posted
August 18, 2015
Record last verified: 2015-07