Phase 2
N=80
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00778102 ↗Enrolled (actual)
80
Serious AEs
62.3%
Results posted
Aug 2015
Primary outcome: Primary: Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor — 48.7; 61.0; 33.3; 51.2 percentage of participants — p=0.2707
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5-FU (Drug); Irinotecan (Drug); Leucovorin (Drug); Oxaliplatin (Drug); bevacizumab [Avastin] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor |
48.7; 61.0; 33.3; 51.2; 23.1; 48.8 | 0.2707 |
| SECONDARY Time to Resection |
4.4; 4.3 | — |
| SECONDARY Percentage of Participants With Histopathological Response |
0; 4.8; 57.1; 47.6; 28.6; 33.3 | — |
| SECONDARY Percentage of Participants With Complete or Major Histopathological Response |
57.1; 52.4 | 0.7817 |
| SECONDARY Percentage of Participants Experiencing Relapse Following Curative Resection |
76.9; 57.1 | — |
| SECONDARY Relapse-Free Survival (RFS) |
8.1; 17.1 | — |
| SECONDARY Percentage of Participants Experiencing Death or Disease Progression |
89.7; 68.3 | — |
| SECONDARY Progression-Free Survival (PFS) |
11.5; 18.6 | — |
| SECONDARY Percentage of Participants Who Died |
48.7; 19.5 | — |
| SECONDARY Overall Survival (OS) |
32.2; NA | — |
| SECONDARY Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 |
61.5; 80.5 | 0.0612 |
| SECONDARY Time to Response |
3.1; 3.1 | — |
| SECONDARY Percentage of Participants With Complications Related to First Resective Surgery |
73.7; 52.0; 15.8; 4.0; 36.8; 12.0 | — |
| SECONDARY Percentage of Participants With Complications Related to Second Resective Surgery |
100.0; 66.7; 0; 33.3; 66.7; 0 | — |
Summary
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- unresectable liver metastasis secondary to cancer of colon or rectum;
- scheduled for standard first line chemotherapy;
- ECOG performance score of 0 or 1;
- condition feasible for major abdominal surgery after first line treatment.
Exclusion Criteria
- diagnosis of metastatic disease >3 months prior to study entry;
- evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
- prior systemic or local treatment of metastatic disease;
- prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
- history or evidence of CNS disease unrelated to cancer.
Data sourced from ClinicalTrials.gov (NCT00778102). 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.