A Study of Avastin (Bevacizumab) Combined 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
ClinicalTrials.gov Identifier:
First received: July 30, 2010
Last updated: October 7, 2013
Last verified: October 2013

This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.

Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Phase 2

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 Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Overall control of disease (defined as overall response rate plus stable disease, by RECIST criteria) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Duration of overall control of disease [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Safety profile of Avastin [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: June 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (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 the chemotherapy regimen


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

Inclusion Criteria:

  • Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
  • Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Exclusion Criteria:

  • Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
  • Untreated brain metastases, spinal cord compression or primary brain tumours;
  • Pregnant or lactating women;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
  • Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
  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: NCT01181609

Angers, France, 49933
Besancon, France, 25030
Boulogne-billancourt, France, 92104
Colmar, France, 68024
Dijon, France, 21079
La Roche Sur Yon, France, 85925
Marseille, France, 13005
Montpellier, France, 34298
Neuilly Sur Seine, France, 92200
Nice, France, 06189
Paris, France, 75679
Pierre Benite, France, 69310
Reims, France, 51092
Saint Herblain, France, 44805
Saint-cloud, France, 92210
Toulouse, France, 31052
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181609     History of Changes
Other Study ID Numbers: ML18559
Study First Received: July 30, 2010
Last Updated: October 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
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 July 22, 2014