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

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ClinicalTrials.gov Identifier: NCT00349336
Recruitment Status : Completed
First Posted : July 7, 2006
Results First Posted : February 26, 2010
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time Zero to Last Measurable Plasma Concentration of Bevacizumab [ Time Frame: 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.

  2. Steady-state Exposure of Bevacizumab From Time Zero to Tau [ Time Frame: 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.

  3. Maximum Serum Concentration of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.

  4. Minimum Serum Concentration of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.

  5. Serum Clearance of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.

  6. Time of Maximum Serum Concentration of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.

  7. Volume of Distribution of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.

  8. Terminal Half-life of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00349336     History of Changes
Other Study ID Numbers: NO20254
First Posted: July 7, 2006    Key Record Dates
Results First Posted: February 26, 2010
Last Update Posted: September 18, 2012
Last Verified: September 2012

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
Growth Inhibitors
Antineoplastic Agents