A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

NCT ID: NCT01159171

Last Updated: 2014-08-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

5 mg/kg intravenously every 14 days

capecitabine [Xeloda]

Intervention Type DRUG

1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle

oxaliplatin

Intervention Type DRUG

40 mg/m2 iv weekly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bevacizumab [Avastin]

5 mg/kg intravenously every 14 days

Intervention Type DRUG

capecitabine [Xeloda]

1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle

Intervention Type DRUG

oxaliplatin

40 mg/m2 iv weekly

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients \>=18 years of age
* Locally advanced or metastatic colorectal cancer
* No previous treatment with chemotherapy for metastatic disease
* Measurable and/or evaluable lesions

Exclusion Criteria

* Radiotherapy within 4 weeks before study
* Untreated brain metastases or primary brain tumors
* Chronic, daily treatment with high-dose aspirin (\>325mg/day)
* Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aviano, , Italy

Site Status

Fano, , Italy

Site Status

Palermo, , Italy

Site Status

Rimini, , Italy

Site Status

Roma, , Italy

Site Status

Torino, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML18523

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.