A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or modified infusional 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (mFOLFOX6) plus bevacizmab administered until first disease progression. Participants will then continue with Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second disease progression. The anticipated time on study treatment is 4 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Capecitabine; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

For resected primary tumor participants, and participants with primary tumor in situ:

• Previously untreated metastatic colorectal cancer and not a candidate for curative resection

• World Health Organization (WHO) performance status of 0-1

• Life expectancy of greater than or equal to (>/=) 3 months

• Eligible for XELOX, mFOLFOX6, FOLFIRI and bevacizumab treatment in accordance with local standards of care and pharmaceutical benefits scheme guidelines

Additional inclusion criteria for participants with primary tumor in situ:

• Intact primary tumor of the colon or the rectum not requiring surgical intervention prior to study start

• Minimal or asymptomatic primary tumor

Exclusion Criteria:

Resected primary tumor participants, and participants with primary tumor in situ:

• Previous chemotherapy for metastatic colorectal cancer

• Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start

• Radiotherapy within 28 days prior to enrollment or not recovered from a radiotherapy

• History of non-colorectal cancer (participants are eligible if disease-free for >/=5 years and the risk of recurrence is deemed low)

• Presence of active inflammatory bowel disease

• History of gastrointestinal perforations

• Peritoneal disease

• History of significant bleeding event

• Significant vascular disease

• Peripheral arterial thrombosis or other thrombotic event within 6 months before study start

Additional exclusion criteria for participants with primary tumor in situ:

• Prior endoscopic management of the current tumor

• Acute diverticulitis

• Presence of intra-abdominal abscess

• Active gastroduodenal ulcer