A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) 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: January 13, 2014
Last verified: January 2014
  Purpose

This 2 arm study will assess the efficacy and safety of Avastin in combination with Xeloda, compared with Xeloda alone, in elderly patients with metastatic colorectal cancer. Patients will be randomized to receive either Avastin (7.5mg/kg iv on day 1 of each 3 week cycle), in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle), or Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle) alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: Xeloda
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 Randomized, Open-label Study to Evaluate the Effect of Avastin in Combination With Xeloda on Progression-free Survival in 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: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response, duration of response, time to response, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 281
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: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Drug: Xeloda
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Active Comparator: 2 Drug: Xeloda
1000mg/m2 po bid on days 1-14 of each 3 week cycle

  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 enrolment;
  • >=1 measurable metastatic lesion.

Exclusion Criteria:

  • adjuvant anti-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 (>325mg/day) or other NSAID, or full dose anticoagulants.
  Contacts and Locations
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
Last Updated: January 13, 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
Capecitabine
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014