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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

This study has been withdrawn prior to enrollment.
(Study was cancelled before patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577109
First Posted: December 19, 2007
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck KGaA
Information provided by:
Hoffmann-La Roche
December 18, 2007
December 19, 2007
August 24, 2016
Not Provided
Not Provided
Progression-free survival [ Time Frame: 12 months ]
Progression-free survival after 12 months.
Complete list of historical versions of study NCT00577109 on ClinicalTrials.gov Archive Site
  • Objective response rate, rate of resection of hepatic metastases, overall survival. [ Time Frame: Event driven ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]
Efficacy: Objective response rate; rate of resection of hepatic metastases; overall survival. Safety: AEs; laboratory parameters.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    5mg/kg iv on day 1 of each 2 week cycle
  • Drug: Irinotecan
    180mg/m2 iv on day 1 of each 2 week cycle
  • Drug: Leucovorin
    200mg/m2 iv on day 1 of each 2 week cycle
  • Drug: 5 FU
    400mg/m2 iv on day 1 of each 2 week cycle
  • Drug: Cetuximab
    Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: Irinotecan
  • Drug: Leucovorin
  • Drug: 5 FU
  • Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
Not Provided

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • colorectal cancer;
  • advanced or recurrent disease;
  • >=1 measurable lesion;
  • >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.

Exclusion Criteria:

  • previous treatment for colorectal cancer;
  • significant history of cardiac disease in past 6 months;
  • other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00577109
ML20452
Not Provided
Not Provided
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Merck KGaA
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP