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
Overview
- Phase
- Phase 3
- Intervention
- bevacizumab [Avastin]
- Conditions
- Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 64
- Primary Endpoint
- Weekly Steady-state Exposure of Bevacizumab
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: bevacizumab [Avastin]
1
Intervention: XELOX
2
Intervention: bevacizumab [Avastin]
2
Intervention: FOLFOX-4
Outcomes
Primary Outcomes
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
- 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)
- Time of Maximum Serum Concentration of Bevacizumab(Up to 48 weeks)
- Volume of Distribution of Bevacizumab at Steady State(Up to 48 weeks)
- Terminal Half-life of Bevacizumab(Up to 48 weeks)