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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00577031
First received: December 18, 2007
Last updated: October 7, 2013
Last verified: October 2013
  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: August 2011
Primary Completion Date: August 2011 (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, 09100
Cagliari, Italy, 09121
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, 90127
Palermo, Italy, 90146
Pavia, Italy, 27100
Reggio Calabria, Italy, 89100
Reggio Emilia, Italy, 42100
Rionero in Vulture, Italy, 85028
Roma, Italy, 00184
Roma, Italy, 00152
Roma, Italy, 00186
Roma, Italy, 00189
Salerno, Italy, 84131
San Giovanni Rotondo, Italy, 71013
Sondrio, Italy, 23100
Taormina, Italy, 98030
Torino, Italy, 10125
Torino, Italy, 10153
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: October 7, 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 April 21, 2014