A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00484939
First received: June 11, 2007
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.


Condition Intervention Phase
Colorectal Cancer
Drug: Bevacizumab
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.


Secondary Outcome Measures:
  • AEs, Laboratory Parameters, Vital Signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.

  • Duration of Response [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.

  • Time to Response [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.

  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time in months from randomization to death from any cause.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months). ] [ Designated as safety issue: No ]
    The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.

  • Percentage of Participants Requiring Additional Treatment for Malignancy [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.

  • Duration of Follow-up [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ] [ Designated as safety issue: No ]
    Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.


Enrollment: 280
Study Start Date: July 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Drug: Bevacizumab
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
Other Name: Avastin
Drug: Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Other Name: Xeloda
Active Comparator: Capecitabine
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Drug: Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, ≥ 70 years of age.
  • Cancer of the colon or rectum.
  • Metastatic disease diagnosed ≤ 6 months before enrollment.
  • ≥ 1 measurable metastatic lesion.

Exclusion Criteria:

  • Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
  • Prior chemotherapeutic treatment for metastatic colorectal cancer.
  • Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
  • Clinically significant cardiovascular disease.
  • Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
  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: NCT00484939

  Hide Study Locations
Locations
Austria
Innsbruck, Austria, 6020
Linz, Austria, 4010
Salzburg, Austria, 5020
Wien, Austria, 1160
Wien, Austria, 1220
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Greece
Larissa, Greece, 41 110
Piraeus, Greece, 18537
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1122
Gyor, Hungary, 9023
Zalaegerszeg-Pozva, Hungary, 8900
Italy
Reggio Emilia, Emilia-Romagna, Italy, 42100
Roma, Lazio, Italy, 00144
Lecce, Puglia, Italy, 73100
Firenze, Toscana, Italy, 50139
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 410-769
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Mexico
Leon, Mexico, 37000
Mexico City, Mexico, 16200
Mexico City, Mexico, 14000
Mexico City, Mexico, 14140
Puebla, Mexico, 72530
Netherlands
Apeldoorn, Netherlands, 7334 DZ
Eindhoven, Netherlands, 5623 EJ
Utrecht, Netherlands, 3527 CE
Poland
Krakow, Poland, 31-826
Krakow, Poland, 30-501
Warszawa, Poland, 02-097
Slovenia
Ljubljana, Slovenia, 1000
Spain
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Leganes, Madrid, Spain, 28911
Barcelona, Spain, 08041
Jaen, Spain, 23007
Madrid, Spain, 28040
Murcia, Spain, 30120
Zaragoza, Spain, 50009
United Kingdom
Bristol, United Kingdom, BS2 8ED
Colchester, United Kingdom, CO3 3NB
Glasgow, United Kingdom, G12 0YN
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, W2 1NY
Manchester, United Kingdom, M20 4BX
Nottingham, United Kingdom, NG5 1PB
Rhyl, United Kingdom, LL18 5UJ
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00484939     History of Changes
Other Study ID Numbers: MO19286
Study First Received: June 11, 2007
Results First Received: March 7, 2014
Last Updated: May 28, 2014
Health Authority: Hungary: Ministry of Health

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
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014