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

Colorectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349336
• Other study ID #: NO20254
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2006
• Last updated: September 12, 2012
• Start date: August 2006
• Est. completion date: November 2008

Study information

• Verified date: September 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
• XELOX
As prescribed
• bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle
• FOLFOX-4
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time Zero to Last Measurable Plasma Concentration of Bevacizumab	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.	Up to 48 weeks	No
Secondary	Steady-state Exposure of Bevacizumab From Time Zero to Tau	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.	Up to 48 weeks	No
Secondary	Maximum Serum Concentration of Bevacizumab at Steady State	Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No
Secondary	Minimum Serum Concentration of Bevacizumab at Steady State	Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No
Secondary	Serum Clearance of Bevacizumab	Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No
Secondary	Time of Maximum Serum Concentration of Bevacizumab	Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No
Secondary	Volume of Distribution of Bevacizumab at Steady State	Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No
Secondary	Terminal Half-life of Bevacizumab	Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks	No