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Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients

NCT00335595 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2013-02-20

No results posted yet for this study

Summary

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.

Conditions

Interventions

DRUG

XELOXA

XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks

DRUG

XELOXA-A

XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study. One cycle every 3 weeks

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Enrique Aranda, MD; phD · Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

  • Eduardo Díaz-Rubio, MD; phD · Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335595 on ClinicalTrials.gov