At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™)
In Brief
A Phase 4 clinical trial evaluating Oxaliplatin, Capecitabine, and 4 other interventions for Colorectal Neoplasms. Completed, enrolled 128 participants across 17 sites.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive oxaliplatin 85 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m\^2 on Day 1 of every 3 weeks cycle during Phase A treatment.
Participants will receive capecitabine 1000 mg/m\^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment.
Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
Participants will receive leucovorin 400 mg/m\^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). Investigators may elect to chose low dose of leucovorin (either 20 mg/m\^2 or 50 mg total dose).
Participants will receive 5-fluouracil loading dose of 400 mg/m\^2 IV on Day 1 followed by 2400 mg/m\^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B).
Participants will receive irinotecan 180 mg/m\^2 IV on Day 1 every 2 weeks during Phase B treatment.