NCT00349336

Brief Summary

This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3 colorectal-cancer

Geographic Reach
3 countries

7 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

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 26, 2010

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

July 6, 2006

Results QC Date

June 2, 2009

Last Update Submit

September 12, 2012

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Weekly Steady-state Exposure of Bevacizumab

    Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.

    Up to 48 weeks

Secondary Outcomes (8)

  • Time Zero to Last Measurable Plasma Concentration of Bevacizumab

    Up to 48 weeks

  • Steady-state Exposure of Bevacizumab From Time Zero to Tau

    Up to 48 weeks

  • Maximum Serum Concentration of Bevacizumab at Steady State

    Up to 48 weeks

  • Minimum Serum Concentration of Bevacizumab at Steady State

    Up to 48 weeks

  • Serum Clearance of Bevacizumab

    Up to 48 weeks

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: bevacizumab [Avastin]Drug: XELOX

2

EXPERIMENTAL
Drug: bevacizumab [Avastin]Drug: FOLFOX-4

Interventions

bevacizumab [Avastin]DRUG

7.5mg/kg iv on day 1 of each 3 week cycle

1
XELOXDRUG

As prescribed

1
FOLFOX-4DRUG

As prescribed

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
  • \>=1 target lesion.

You may not qualify if:

  • patients who have previously received systemic treatment for advanced or metastatic disease;
  • patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
  • previous therapy with oxaliplatin or Avastin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Box Hill, 3128, Australia

Location

Unknown Facility

Fitzroy, 3065, Australia

Location

Unknown Facility

Sydney, 2031, Australia

Location

Unknown Facility

Brampton, Ontario, L6R 3J7, Canada

Location

Unknown Facility

Hamilton, Ontario, L8V 5C2, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabXELOXFolfox protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

August 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 18, 2012

Results First Posted

February 26, 2010

Record last verified: 2012-09

Locations

NZ(1)AU(3)CA(3)