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A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Neoplasms

Interventions: Oxaliplatin, Capecitabine, Bevacizumab, Leucovorin, 5-Fluouracil

Countries: Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (17)

Garran, Australian Capital Territory, Australia
Campbelltown, New South Wales, Australia
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Port Macquarie, New South Wales, Australia
St Leonards, New South Wales, Australia
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Rockhampton, Queensland, Australia
Townsville, Queensland, Australia
Elizabeth Vale, South Australia, Australia
North Adelaide, South Australia, Australia
Launceston, Tasmania, Australia
Heidelberg, Victoria, Australia
St Albans, Victoria, Australia
Murdoch, Western Australia, Australia
Subiaco, Western Australia, Australia