ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

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.
ClinicalTrials.gov Identifier: NCT01506167
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.

Condition or disease Intervention/treatment
Colorectal Cancer Drug: Bevacizumab Drug: Capecitabine/Oxaliplatin Drug: Fluorouracil/Folinic Acid/Oxaliplatin Drug: Capecitabine Drug: Fluorouracil/Folinic Acid/Irinotecan Drug: Fluorouracil +/- Folinic Acid

Study Type : Observational
Actual Enrollment : 719 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
Actual Study Start Date : July 6, 2012
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Drug: Capecitabine/Oxaliplatin
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment

Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Drug: Fluorouracil/Folinic Acid/Oxaliplatin
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment

Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Drug: Capecitabine
Capecitabine was administered along with bevacizumab as part of standard first-line treatment

Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Drug: Fluorouracil/Folinic Acid/Irinotecan
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment

Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®

Drug: Fluorouracil +/- Folinic Acid
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment

Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
Drug: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Other Name: Avastin®




Primary Outcome Measures :
  1. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: 1.5 years ]
    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires new in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.

  2. Percentage of Participants with Grade 3-5 Avastin Related Adverse Events [ Time Frame: 1.5 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. Adverse events were graded according to NCI-CTCAE, v4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0).

  3. Progression-Free Survival [ Time Frame: 1.5 years ]
    Progression-Free Survival (PFS) was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. PFS was assessed using Kaplan-Meier method.

  4. Overall Survival [ Time Frame: 1.5 years ]
    Overall Survival (OS) is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause.


Secondary Outcome Measures :
  1. Percentage of Participants with Avastin Related Adverse Events of Special Interest [ Time Frame: 1.5 years ]
    Adverse events of special interest (AESIs) are defined by their possible association with Avastin® treatment. The adverse events of special interest in this study include all grades of gastrointestinal perforation, fistulae, arterial and venous thromboembolic events, congestive heart failure and pulmonary haemorrhages; and Grade 2-5: hypertension, wound healing complications, proteinuria and mucocutaneous haemorrhages.

  2. Reasons for Discontinuation of Avastin [ Time Frame: 1.5 years ]
  3. Median Progression Free Survival from Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    PFS was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median PFS is presented for data from other registration trials and similar observational studies.

  4. Median Overall Survival from Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    OS is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median OS is presented for data from other registration trials and similar observational studies.

  5. Percentage of Participants with Comparative AEs from Four Avastin® Studies [ Time Frame: 1.5 years (ACORN) ]
    Comparative AEs included Gastrointestinal perforation; Haemorrhage (specific grade); All Haemorrhages; Hypertension; and Arterial thromboembolic events (cerebrovascular accident, myocardial infarction, transient ischaemic attack and other). The specific grade of haemorrhage was 3/4 for BRITE, 3/4 for BEAT and 3-5 for ARIES. The specific grade for ACORN was unknown. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  6. Median Age of Participants in Four Avastin® Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  7. Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  8. Percentage of Males and Females in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  9. Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    ECOG Performance Status measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  10. Race/Ethnicity of Participants in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  11. Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  12. Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  13. Sites of CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  14. Percentage of Participants with Primary Resection in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  15. Metastatic Sites of CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  16. Ongoing Patient Medical Conditions in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.

  17. Weeks of Further Treatment After 1st Line Chemotherapy [ Time Frame: From disease progression until end of study. ]
    Number of weeks of further chemotherapy regimen administered after 1st line treatment.

  18. Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
    The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D weighted index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.

  19. Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
    The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.

  20. Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  21. Response to the Burden of Illness Question: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  22. Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  23. Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  24. Response to the Burden of Illness Question: What was your employment status before diagnosis? [ Time Frame: Baseline ]
  25. Response to the Burden of Illness Question: What is your employment status now? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  26. Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  27. Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  28. Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]


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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients diagnosed with metastatic colorectal cancer
Criteria

Inclusion Criteria:

  • Metastatic colorectal cancer with no previous systemic treatment for advanced disease
  • Receiving Avastin in combination with a first-line standard of care chemotherapy regimen
  • Avastin initiated at the same time as first-line chemotherapy regimen

Exclusion Criteria:

  • Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
  • Contraindication to Avastin

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): NCT01506167


Locations
United Kingdom
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
Bath, United Kingdom, BA1 3NG
Wexham Park Hospital; Oncology
Berkshire, United Kingdom, SL2 4HL
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, United Kingdom, B9 5SS
Bishop Auckland Hospital;Oncology Department
Bishop Auckland, United Kingdom, DL14 6AD
University Hospital of North Staffordhire
Blackpool, United Kingdom, FY3 8NR
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford, United Kingdom, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
West Suffolk Hospital Nhs Trust; Gi Corridor
Bury St Edmunds, United Kingdom, IP33 2QZ
Kent & Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Cumberland Infirmary; Oncology Department
Carlisle, United Kingdom, CA2 7HY
Broomfield Hospital; Oncology
Chelsmford, United Kingdom, CM1 7ET
University Hospital North Tees
Cleveland, United Kingdom, TS19 8PE
Castle Hill Hospital; Academic Oncology
Cottingham, United Kingdom, HU16 5JQ
Darlington Memorial Hospital
Darlington, United Kingdom, DL3 6HX
Russells Hall Hospital; Dept of Hematology
Dudley, United Kingdom, DY1 2HQ
University Hospital of North Durham; Oncology
Durham, United Kingdom, DH15TW
Harrogate Hospital
Harrogate, United Kingdom, HG2 8AY
Northhwick Park Hospital;Oncology Department
Harrow, United Kingdom, HA1 3UJ
Ipswich Hospital; Oncology Pharmacy
Ipswich, United Kingdom, IP4 5PD
Kidderminster Hospital; Oncology Dept
Kidderminster, United Kingdom, DY11 6RJ
Royal Free Hospital; Dept of Oncology
London, United Kingdom, NW3 2QG
Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
London, United Kingdom, SE1 9RT
Queen Elizabeth Hospital
London, United Kingdom, SE18 4QH
Macclesfield District General Hospital
Macclesfield, United Kingdom, SK10 3BL
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, United Kingdom, ME16 9QQ
The James Cook University Hospital
Middlesborough, United Kingdom, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
North Tyneside General Hospital
North Shields, United Kingdom, NE29 8NH
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Nottingham University Hospitals City Campus
Nottingham, United Kingdom, NG5 1PB
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, United Kingdom, PE3 9GZ
Derriford Hospital; Gastroenterology
Plymouth, United Kingdom, PL6 8DH
Queen's Hospital
Romford, United Kingdom, RM7 0AG
Scunthorpe General Hospital; Dept of Oncology
Scunthorpe, United Kingdom, DN16 7BH
Stafford Hospital; Oncology Department
Stafford, United Kingdom, ST16 3SA
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, United Kingdom, SN3 6BB
Torbay Hospital; Oncology
Torquay, United Kingdom, TQ2 7AA
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, United Kingdom, TR1 3LJ
Walsall Manor Hospital
Walsall, United Kingdom, WS2 9PS
Royal Hampshire County Hospital; Winchester & Andover Breast Unit
Winchester, United Kingdom, SO22 5DG
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01506167     History of Changes
Other Study ID Numbers: ML27971
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No

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
Oxaliplatin
Irinotecan
Capecitabine
Camptothecin
Fluorouracil
Leucovorin
Folic Acid
Levoleucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic