Phase 2
Completed N=103
Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01622543 ↗Enrolled (actual)
103
Serious AEs
38.8%
Results posted
Dec 2019
Primary outcomePrimary: Progression Free Survival — 7.33; 9.13 Months — p=0.046
Summary
The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
7.33; 9.13 | 0.046 sig |
| SECONDARY Changes in CEA Levels |
-14209.4; -1107.99 | 0.45 |
| SECONDARY Objective Response Rate |
27; 18 | 0.06 |
| SECONDARY Overall Survival |
19.3; 20.0 | 0.36 |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histological diagnosis of colorectal adenocarcinoma.
- All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block.
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). All patients must have measurable disease as defined by RECIST 1.1.
The criteria for defining measurable disease are as follows:
Chest X-ray ≥ 20 mm CT/MRI scan (with slice thickness of grade 1.
- Patients who are not sterile unless they use an adequate method of birth control.
Data sourced from ClinicalTrials.gov (NCT01622543). 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.