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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

18 and over

Pharmaceutical / Industry

ML21380
NCT00577031

Trial Description

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Please reference Study ID Number: RLI_ML21380

Ph: 973-235-5000

Ph: 800-526-6367 (FOR US ONLY)

Trial Sites

Italy

BOLOGNA

Study Site

BRESCIA

Study Site

CAGLIARI

Study Site

CASERTA

Study Site

CATANZARO

Study Site

CEFALU

Study Site

FIRENZE

Study Site

FRATTAMINORE

Study Site

GROSSETO

Study Site

LEGNAGO

Study Site

MACERATA

Study Site

NEGRAR

Study Site

ORBASSANO

Study Site

PADOVA

Study Site

PALERMO

Study Site

PAVIA

Study Site

REGGIO CALABRIA

Study Site

REGGIO EMILIA

Study Site

RIONERO IN VULTURE

Study Site

ROMA

Study Site

SALERNO

Study Site

SAN GIOVANNI ROTONDO

Study Site

VERBANIA

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00577031
Information obtained from ClinicalTrials.gov on September 18, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.