An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

Colorectal Cancer Clinical Trial

Official title:

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830647
• Other study ID #: ML28411
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: November 1, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Montenegro: Agency for Medicines and Medical Devices of Montenegro
• Study type: Observational

Clinical Trial Summary

This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases

• At least one measurable metastatic lesion (as per RECIST criteria)

• Life expectancy of > 12 weeks

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Adequate hematological, renal and liver function

Exclusion Criteria:

• Prior chemotherapy for metastatic disease

• Clinically significant cardiovascular disease

• Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration

• Participation in an investigational trial in the previous 3 months

• Pregnant or lactating women

• History of thrombotic or haemorrhagic disorders

• Evidence of bleeding diathesis or coagulopathy

• Uncontrolled hypertension

• Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies

• Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Montenegro, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3.5 years	No
Secondary	Efficacy: Time to disease progression		approximately 3.5 years	No