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An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases (PICASSO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343901
First Posted: April 28, 2011
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.

Condition Intervention
Colorectal Cancer Drug: Bevacizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery [ Time Frame: Baseline up to 36 months ]
    Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).

  • Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery [ Time Frame: Baseline up to 36 months ]
    The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.


Secondary Outcome Measures:
  • Percentage of Participants With at Least One Disease and Comorbidity at Day 0 [ Time Frame: Day 0 ]
    Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.

  • Percentage of Participants With Different Previous Therapies at Day 0 [ Time Frame: Day 0 ]
    Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.

  • Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period [ Time Frame: Baseline up to 36 months ]
  • Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period [ Time Frame: Baseline up to 36 months ]
  • Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment [ Time Frame: Baseline up to 36 months ]
    Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.

  • Percentage of Participants With Disease Progression or Death [ Time Frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months ]
    Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.

  • Progression-free Survival (PFS) [ Time Frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months ]
    Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.

  • Percentage of Participants With Disease Relapse [ Time Frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months ]
    Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.

  • Relapse-free Survival (RFS) [ Time Frame: Baseline until disease progression or death, whichever occurred first, assessed up to 36 months ]
    RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.

  • Percentage of Participants Who Died [ Time Frame: Baseline until death; assessed up to 36 months ]
  • Overall Survival (OS) [ Time Frame: Baseline until death, assessed up to 36 months ]
    OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

  • Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery [ Time Frame: Baseline up to 36 months ]
    For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).

  • Number of Cumulated Cycles of First Line Bevacizumab at Day 0 [ Time Frame: Day 0 ]
  • Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0 [ Time Frame: Day 0 ]
  • Total Duration of First Line Bevacizumab Treatment at Day 0 [ Time Frame: Day 0 ]
  • Percentage of Participants With Unresectability Criteria [ Time Frame: Day 0 ]

Enrollment: 210
Actual Study Start Date: September 30, 2010
Study Completion Date: June 30, 2015
Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bevacizumab
Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed.
Drug: Bevacizumab
Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.
Other Name: Avastin

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with colorectal cancer and hepatic or hepatic and pulmonary metastases
Criteria

Inclusion Criteria:

  • Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
  • First-line treatment with bevacizumab for potentially resectable metastatic disease

Exclusion Criteria:

  • Outright resectable disease
  • Clearly inoperable disease
  • Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343901


  Show 126 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01343901     History of Changes
Other Study ID Numbers: ML22999
First Submitted: April 27, 2011
First Posted: April 28, 2011
Results First Submitted: March 15, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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
Growth Inhibitors
Antineoplastic Agents