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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01181609
First received: July 30, 2010
Last updated: July 24, 2014
Last verified: July 2014
  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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Achieving Overall Disease Control (ODC) [ Time Frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a Best Overall Response of CR or PR [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

  • Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.

  • PFS - Time to Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.

  • Duration of Response [ Time Frame: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.

  • Duration of Overall Disease Control [ Time Frame: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.

  • Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from start of study treatment to death from any cause.

  • OS - Time to Event [ Time Frame: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) ] [ Designated as safety issue: No ]
    OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.


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

  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
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

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, 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
Investigators
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
Results First Received: June 4, 2014
Last Updated: July 24, 2014
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 August 28, 2014