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

Roche

Status: Completed

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01830647

ML28411

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

35 participants in 1 patient group

Cohort