An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01830647
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 3.5 years
- Secondary Outcome Measures
Name Time Method Efficacy: Time to disease progression approximately 3.5 years