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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01830647

Enrollment

Registered

2013-04-12

Start date

2013-04-30

Completion date

2016-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 3.5 years

Secondary

Measure	Time frame
Efficacy: Time to disease progression	approximately 3.5 years

Countries

Montenegro

Outcome results