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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This study has been withdrawn prior to enrollment.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
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Drug: bevacizumab [Avastin] Drug: Irinotecan Drug: Leucovorin Drug: 5 FU Drug: Cetuximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Objective response rate, rate of resection of hepatic metastases, overall survival. [ Time Frame: Event driven ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]

Enrollment: 0
Study Completion Date: June 2012
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

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;
  • 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.
  Contacts and Locations
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): NCT00577109


Locations
Brazil
Salvador, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Sponsors and Collaborators
Hoffmann-La Roche
Merck KGaA
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00577109     History of Changes
Other Study ID Numbers: ML20452
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: August 24, 2016
Last Verified: August 2016

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
Irinotecan
Cetuximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action