OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00577031

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 IV

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Capecitabine Bevacizumab Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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'

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 ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2011

Arms	Assigned Interventions
1: Experimental	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

Contacts

Contact: Please reference Study ID Number: ML21380	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Italy
	Recruiting
FIRENZE, Italy, 50139
	Recruiting
PALERMO, Italy, 90127
	Recruiting
GROSSETO, Italy, 58100
	Recruiting
ROMA, Italy, 00184
	Recruiting
LEGNAGO, Italy, 37045
	Recruiting
REGGIO EMILIA, Italy, 42100
	Recruiting
SALERNO, Italy, 84131
	Recruiting
PADOVA, Italy, 35128
	Recruiting
NAPOLI, Italy, 80131
	Not yet recruiting
PAVIA, Italy, 27100
	Recruiting
FRATTAMINORE, Italy, 80026
	Recruiting
ORBASSANO, Italy, 10043
	Recruiting
LEGNANO, Italy, 20025
	Recruiting
TORINO, Italy, 10125
	Not yet recruiting
PIOVE DI SACCO, Italy, 35028
	Not yet recruiting
LATISANA, Italy, 33053
	Recruiting
MACERATA, Italy, 62100
	Not yet recruiting
LECCE, Italy, 73100
	Recruiting
SAN GIOVANNI ROTONDO, Italy, 71013
	Recruiting
BOLOGNA, Italy, 40138
	Recruiting
CAGLIARI, Italy, 09100
	Recruiting
CATANZARO, Italy, 88100
	Recruiting
FANO, Italy, 61032
	Recruiting
REGGIO CALABRIA, Italy, 89100
	Recruiting
PAVIA, Italy, 27100
	Recruiting
NEGRAR, Italy, 37024
	Recruiting
ROMA, Italy, 00189
	Recruiting
IVREA, Italy, 10015
	Recruiting
BRESCIA, Italy, 25122
	Recruiting
CASERTA, Italy, 81100
	Recruiting
CEFALU, Italy, 90015
	Not yet recruiting
LANCIANO, Italy, 66034
	Recruiting
RIONERO IN VULTURE, Italy, 85028
	Recruiting
ROMA, Italy, 00186
	Recruiting
ROMA, Italy, 00149
	Not yet recruiting
VENEZIA, Italy, 30125
	Recruiting
VERBANIA, Italy, 28921
	Not yet recruiting
MESTRE (VE), Italy, 30172
	Not yet recruiting
ESTE, Italy, 35042
	Recruiting
TORINO, Italy, 10153
	Not yet recruiting
TAORMINA, Italy, 98039
	Recruiting
PALERMO, Italy, 90146
	Not yet recruiting
ZINGONIA (BG), Italy, 24040
	Not yet recruiting
SONDRIO, Italy, 23100
	Recruiting
CAGLIARI, Italy, 09121

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21380
Study First Received:	December 18, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00577031
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Bevacizumab
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Antineoplastic Agents
Growth Substances

Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009