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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01266564
First received: December 20, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will assess the progression-free survival, overall resp onse and safety of Avastin (bevacizumab) in combination with chemotherapy in a r eal life setting in patients with metastatic colorectal cancer. Data will be col lected 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:


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 ]

Enrollment: 210
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
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: NCT01266564

Locations
Lebanon
Beirut, Lebanon, 99999
Beirut, Lebanon, 470 Hazmieh
Beirut, Lebanon, 11-236
Beirut, Lebanon, 166378
Beirut, Lebanon
Dora, Lebanon
El Chouf, Lebanon, 1503-2010
El- Metn, Lebanon, 295
Jbeil, Lebanon, 1401
Saida, Lebanon, 652
Tripoli, Lebanon, 371 Tripoli
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: August 4, 2014
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 August 28, 2014