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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Weekly Steady-state Exposure of Bevacizumab

Outcome Description:

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.

Outcome Time Frame:

Up to 48 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO20254

NCT ID:

NCT00349336

Start Date:

August 2006

Completion Date:

November 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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