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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01169558
First received: July 22, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This expanded access study will assess the efficacy and safety of intravenous Av astin (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with flu oropyrimidine-based chemotherapy as first line treatment of patients with metast atic 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01169558

Locations
Brazil
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, 90035-903
Porto Alegre, Brazil, 90020-090
Recife, Brazil, 52012-220
Ribeirao Preto, Brazil, 14025-430
Rio de Janeiro, Brazil, 22631-004
Rio de Janeiro, Brazil, 22031072
Salvador, Brazil, 40170-110
Salvador, Brazil, 41950-610
Salvador, Brazil, 41810-012
Sao Paulo, Brazil, 01406100
Sao Paulo, Brazil, 01229-000
Sao Paulo, Brazil, 05651-901
Sao Paulo, Brazil, 01232-010
Sao Paulo, Brazil, 04122-000
Sao Paulo, Brazil, 01332-000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01169558     History of Changes
Other Study ID Numbers: ML20552
Study First Received: July 22, 2010
Last Updated: August 4, 2014
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
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 September 22, 2014