A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00349336
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- adult patients, >=18 years of age;
- adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
- >=1 target lesion.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 XELOX - 2 bevacizumab [Avastin] - 2 FOLFOX-4 -
- Primary Outcome Measures
Name Time Method Weekly Steady-state Exposure of Bevacizumab 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 Outcome Measures
Name Time Method Time Zero to Last Measurable Plasma Concentration of Bevacizumab 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.
Steady-state Exposure of Bevacizumab From Time Zero to Tau 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.
Maximum Serum Concentration of Bevacizumab at Steady State Up to 48 weeks Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.
Minimum Serum Concentration of Bevacizumab at Steady State Up to 48 weeks Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.
Serum Clearance of Bevacizumab Up to 48 weeks Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Time of Maximum Serum Concentration of Bevacizumab Up to 48 weeks Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Volume of Distribution of Bevacizumab at Steady State Up to 48 weeks Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.
Terminal Half-life of Bevacizumab Up to 48 weeks Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.