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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00349336
First received: July 6, 2006
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: XELOX
Drug: FOLFOX-4
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Weekly Steady-state Exposure of Bevacizumab [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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:
  • Time Zero to Last Measurable Plasma Concentration of Bevacizumab [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.

  • Serum Clearance of Bevacizumab [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.

  • Time of Maximum Serum Concentration of Bevacizumab [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.

  • Volume of Distribution of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.

  • Terminal Half-life of Bevacizumab [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.


Enrollment: 64
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Drug: XELOX
As prescribed
Experimental: 2 Drug: bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle
Drug: FOLFOX-4
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349336

Locations
Australia
Box Hill, Australia, 3128
Fitzroy, Australia, 3065
Sydney, Australia, 2031
Canada, Ontario
Brampton, Ontario, Canada, L6R 3J7
Hamilton, Ontario, Canada, L8V 5C2
Toronto, Ontario, Canada, M5G 2M9
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00349336     History of Changes
Other Study ID Numbers: NO20254
Study First Received: July 6, 2006
Results First Received: June 2, 2009
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014