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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 22, 2010
Last updated: February 1, 2016
Last verified: February 2016
This expanded access study will assess the efficacy and safety of intravenous Avastin (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment of patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Access Program of Avastin in Patients With Metastatic Cancer of Colon or Rectum - Brazilian Extension Study

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Serious and specific adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Duration of survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Efficacy: Time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to chemotherapy regimen


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated metastatic colon or rectal cancer;
  • Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion Criteria:

  • Prior chemotherapy for metastatic colon or rectal cancer;
  • Planned radiotherapy for underlying disease;
  • central nervous system metastases;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
  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 identifier: NCT01169558

Belo Horizonte, Brazil, 30140-083
Belo Horizonte, Brazil, 30150-221
Belo Horizonte, Brazil, 30150321
Brasilia, Brazil, 70390-150
Brasilia, Brazil, 70710-904
Campinas, Brazil, 13073-400
Campinas, Brazil, 13084-759
Caxias Do Sul, Brazil, 95020-450
Curitiba, Brazil, 80530-010
Curitiba, Brazil, 80730-180
Fortaleza, Brazil, 60741-420
Ijui, Brazil, 98700-000
Joao Pessoa, Brazil, 58040280
Porto Alegre, Brazil, 90020-090
Porto Alegre, Brazil, 90035-903
Recife, Brazil, 52012-220
Ribeirao Preto, Brazil, 14025-430
Rio de Janeiro, Brazil, 22031072
Rio de Janeiro, Brazil, 22631-004
Salvador, Brazil, 40170-110
Salvador, Brazil, 41810-012
Salvador, Brazil, 41950-610
Sao Paulo, Brazil, 01229-000
Sao Paulo, Brazil, 01232-010
Sao Paulo, Brazil, 01332-000
Sao Paulo, Brazil, 01406100
Sao Paulo, Brazil, 04122-000
Sao Paulo, Brazil, 05651-901
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01169558     History of Changes
Other Study ID Numbers: ML20552 
Study First Received: July 22, 2010
Last Updated: February 1, 2016
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on September 26, 2016