Status:
COMPLETED
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01830647
Start Date
April 1 2013
End Date
April 1 2016
Last Update
November 2 2016
Active Locations (1)
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1
Podgorica, Montenegro, 81000