Phase 4
Completed N=128
A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01588990 ↗Enrolled (actual)
128
Serious AEs
67.2%
Results posted
Jan 2019
Primary outcomePrimary: Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio — 1.4 hazard ratio — p=0.101
◆ Published Evidence
Emerging
18citations · ~1 / year
An Australian translational study to evaluate the prognostic role of inflammatory markers in patients with metastatic ColorEctal caNcer Treated with bevacizumab (Avastin™) [ASCENT].
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.
Linked Publications (2)
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An Australian translational study to evaluate the prognostic role of inflammatory markers in patients with metastatic ColorEctal caNcer Treated with bevacizumab (Avastin™) [ASCENT].
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The prognostic role of inflammatory markers in patients with metastatic colorectal cancer treated with bevacizumab: A translational study [ASCENT].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio |
1.4 | 0.101 |
| SECONDARY PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A |
9.2 | — |
| SECONDARY PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B |
6.7 | — |
| SECONDARY Time to Failure of Strategy (TFS): Overall |
14.8 | — |
| SECONDARY Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall |
14.0 | — |
| SECONDARY Overall Survival (OS) From the Start of Treatment to Study Completion: Overall |
25.0 | — |
| SECONDARY Survival Beyond First Disease Progression: Overall |
12.6 | — |
| SECONDARY OS: Phase B |
14.9 | — |
| SECONDARY Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A |
3.1; 8.6 | — |
| SECONDARY Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B |
0; 0 | — |
| SECONDARY Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall |
3.1; 8.6 | — |
| SECONDARY Percentage of Participants Who Underwent Liver Resection: Overall |
1.6 | — |
| SECONDARY Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio |
1.6 | 0.052 |
| SECONDARY Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio |
0.9 | 0.797 |
| SECONDARY Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio |
1.3 | 0.188 |
| SECONDARY Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio |
2.2 | 0.016 sig |
| SECONDARY European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A |
0.830; 0.857; 0.865; 0.853; 0.869; 0.892 | — |
| SECONDARY EuroQol-5D Utility Score: Phase B |
0.814; 0.859; 0.894; 0.897; 0.866; 0.837 | — |
| SECONDARY Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A |
0.747; 0.760; 0.767; 0.796; 0.800; 0.831 | — |
| SECONDARY AQoL-8D Global Utility Score: Phase B |
0.736; 0.773; 0.813; 0.878; 0.808; 0.809 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A |
103.84; 103.33; 106.34; 109.66; 109.39; 111.30 | — |
| SECONDARY FACT-C Score: Phase B |
103.47; 108.71; 108.19; 114.89; 110.60; 111.28 | — |
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
Data sourced from ClinicalTrials.gov (NCT01588990) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.