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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01181609
First received: July 30, 2010
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181609

Locations
France
Angers, France, 49933
Besancon, France, 25030
Boulogne-billancourt, France, 92104
Colmar, France, 68024
Dijon, France, 21079
La Roche Sur Yon, France, 85925
Marseille, France, 13385
Montpellier, France, 34298
Nantes, France, 44805
Neuilly Sur Seine, France, 92200
Nice, France, 06189
Paris, France, 75679
Pierre Benite, France, 69495
Reims, France, 51092
St Cloud, France, 92210
Toulouse, France, 31052
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181609     History of Changes
Other Study ID Numbers: ML18559
Study First Received: July 30, 2010
Last Updated: September 19, 2011
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
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 May 22, 2013