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

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. Identifier: NCT01266564
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Colorectal Cancer

Study Type : Observational
Actual Enrollment : 205 participants
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
Actual Study Start Date : September 3, 2010
Actual Primary Completion Date : July 10, 2015
Actual Study Completion Date : July 10, 2015

Resource links provided by the National Library of Medicine

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


Primary Outcome Measures :
  1. Progression-free survival in a real life setting assessed by computer tomography [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Overall response rate assessed by computer tomography [ Time Frame: Approximately 2 years ]
  2. Response of Avastin according to the sites of metastases assessed by computer tomography [ Time Frame: Approximately 2 years ]
  3. Chemotherapy regimens used in combination with Avastin [ Time Frame: Approximately 2 years ]
  4. Patient demographics eligible to receive Avastin [ Time Frame: Approximately 2 years ]
  5. Safety: incidence of adverse events [ Time Frame: Approximately 2 years ]

Information from the National Library of Medicine

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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
Colorectal cancer patients receiving Avastin in combination with chemotherapy

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

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 identifier (NCT number): NCT01266564

American University of Beirut - Medical Center
Beirut, Lebanon, 11-236
Saint George Hospital; Haematology-Oncology
Beirut, Lebanon, 166378
Hotel Dieu de France; Oncology
Beirut, Lebanon, 16830
Mount Lebanon Hospital
Beirut, Lebanon, 470 Hazmieh
Beirut Governmental University Hospital
Beirut, Lebanon, 99999
Al-Rassoul Al-Aazam Hospital
Beirut, Lebanon
Lebanese Hospital Geitaoui
Beirut, Lebanon
Middle East Inst. of Health; Oncology
Beirut, Lebanon
Saint Joseph Hospital
Dora, Lebanon
Ain Wa Zein Hospital
El Chouf, Lebanon, 1503-2010
Bellevue Medical Center
El- Metn, Lebanon, 295
Notre Dame Des Secours Hospital
Jbeil, Lebanon, 1401
Hammoud Hospital
Saida, Lebanon, 652
Haykal Hospital
Tripoli, Lebanon, 371 Tripoli
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01266564     History of Changes
Other Study ID Numbers: ML25198
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents