A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2016-03-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• histologically confirmed locally advanced rectal cancer;

• measurable disease;

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

• prior treatment with bevacizumab;

• prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;

• previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);

• history or evidence of central nervous system (CNS) disease;

• clinically significant cardiovascular disease;

• chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.