NCT01077739|CompletedPhase 2Results

A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination

Hoffmann-La Roche ClinicalTrials.gov

Compare

2 other identifiers

ML225192009-012090-36

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2010

StartedJul 2009

CompletionJan 2012

Brief Summary

This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda \[capecitabine\] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline

Completed

Started Jul 2009

Geographic Reach

1 country

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

July 1, 2009

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed

Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

February 26, 2010

Results QC Date

July 15, 2014

Last Update Submit

December 8, 2014

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months

Secondary Outcomes (3)

PFS From the Start of First-Line Therapy
Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months

Study Arms (1)

Avastin (bevacizumab) + standard of care

EXPERIMENTAL

Drug: fluorouracil (5FU)Drug: leucovorinDrug: bevacizumab [Avastin]Drug: capecitabine [Xeloda]Drug: oxaliplatin