Randomized, Multicenter, Phase III Study, to Evaluate the Efficacy and Safety of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy After Initial Chemotherapy Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country480 target enrollmentJuly 2006

ConditionsColorectal Cancer

InterventionsXELOXA XELOXA-A

DrugsXELOXA XELOXA-A

Overview

Phase: Phase 3
Intervention: XELOXA
Conditions: Colorectal Cancer
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 480
Locations: 1
Primary Endpoint: Determine the free time to disease progression
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent given.
•Patients who are able to understand the study request.
•Men and women \> or = 18 years, not hospitalized.
•Outpatients with ECOG performance status ≤
•Histologically confirmed diagnosis of colorectal cancer (CRC) patients with metastasis.
•Presence of at least one detectable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
•Life expectancy of greater than 3 months.
•Men and women potentially fertile using an effective contraceptive method

Exclusion Criteria

•Patients who have been treated with bevacizumab previously.
•Received any systemic treatment previously to treat an advanced or metastatic disease
•Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that it has been finished at least 6 months before the initial study treatment.
•If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during treatment or for 6 months after the end of treatment.
•If radiotherapy has not been administered in the lesion selected for the study, previous radiotherapy is allowed, unless progression of those injuries can be documented in the radiated field, as long as the end of the treatment has been finished at least 4 weeks before study initiation.
•Previous surgical procedure of stage IV disease is allowed.
•Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or this study indication, unless there has been a disease-free interval of at least 2 years.
•History or evidence upon physical examination of central nervous system
•History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
•Clinically significant cardiovascular disease (active).

Arms & Interventions

1

XELOXA

Intervention: XELOXA

2

XELOXA-A

Intervention: XELOXA-A

Outcomes

Primary Outcomes

Determine the free time to disease progression

Time Frame: 2006-2012

Secondary Outcomes

Prognostic factor of the K-Ras gene mutation(2006-2012)
Overall survival(2006-2012)
Overall response rate(2006-2012)
Time to onset of response(2006-2012)
Duration of response(2006-2012)
Treatment cycles number(2006-2012)
Number of patients who need medicine dose reduction(2006-2012)
adverse events(2006-2012)
Prognostic and predictive factor of Circulating endothelial cells (CEC) and circulating tumors cells (CTC) baseline and after 3 cycle(2006-2012)