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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01266564
First received: December 20, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival in a real life setting assessed by computer tomography [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate assessed by computer tomography [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Response of Avastin according to the sites of metastases assessed by computer tomography [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Chemotherapy regimens used in combination with Avastin [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Patient demographics eligible to receive Avastin [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Colorectal cancer patients receiving Avastin in combination with chemotherapy

Criteria

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Proven metastatic colorectal carcinoma
  • Patients have measurable disease
  • Patients are eligible to receive first-line Avastin
  • Patients have signed data release form

Exclusion Criteria:

  • Contra-indication to receive Avastin according to the local labeling
  • Participation in a clinical study within 30 days prior to enrolment
  • Patients have any other primary cancer
  • Concomitant treatment with other biologics
  • History of other malignant disease in the past 5 years except basal cell carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266564

Contacts
Contact: Please reference Study ID Number: ML25198 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Lebanon
Recruiting
Beirut, Lebanon, 99999
Completed
Beirut, Lebanon
Recruiting
Beirut, Lebanon, 470 Hazmie
Recruiting
Beirut, Lebanon, 166378
Recruiting
Beirut, Lebanon, 11-236
Recruiting
Beirut, Lebanon
Recruiting
Dora, Lebanon
Recruiting
El Chouf, Lebanon, 1503-2010
Recruiting
El- Metn, Lebanon, 295
Recruiting
Jbeil, Lebanon, 1401
Recruiting
Saida, Lebanon, 652
Recruiting
Tripoli, Lebanon, 371 Tripol
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: NCT01266564     History of Changes
Other Study ID Numbers: ML25198
Study First Received: December 20, 2010
Last Updated: May 7, 2013
Health Authority: Lebanon: Ministry of Public 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
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 May 22, 2013