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Completed

NCT Number: NCT00349336

A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Box Hill, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

bevacizumab [Avastin]

Drug

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

XELOX

Drug

As prescribed

FOLFOX-4

Drug

As prescribed

Primary outcomes

  1. Weekly Steady-state Exposure of Bevacizumab

    Time frame: Up to 48 weeks

    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.

Secondary outcomes

  1. Time Zero to Last Measurable Plasma Concentration of Bevacizumab

    Time frame: Up to 48 weeks

    Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.

  2. Steady-state Exposure of Bevacizumab From Time Zero to Tau

    Time frame: Up to 48 weeks

    Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.

  3. Maximum Serum Concentration of Bevacizumab at Steady State

    Time frame: Up to 48 weeks

    Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.

  4. Minimum Serum Concentration of Bevacizumab at Steady State

    Time frame: Up to 48 weeks

    Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.

  5. Serum Clearance of Bevacizumab

    Time frame: Up to 48 weeks

    Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.

  6. Time of Maximum Serum Concentration of Bevacizumab

    Time frame: Up to 48 weeks

    Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.

  7. Volume of Distribution of Bevacizumab at Steady State

    Time frame: Up to 48 weeks

    Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.

  8. Terminal Half-life of Bevacizumab

    Time frame: Up to 48 weeks

    Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Trial to Assess the Steady State Pharmacokinetics of Avastin Given With Either XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 7, 2006
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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