Phase 2
N=338
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
Neoplasm Metastasis · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00125034 ↗Enrolled (actual)
338
Serious AEs
30.8%
Results posted
Oct 2011
Primary outcome: Primary: Best Overall Response Rate - Independent Review Committee (IRC) — 45.6; 35.7 percentage of participants — p=0.064
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Biological); Oxaliplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate - Independent Review Committee (IRC) |
45.6; 35.7 | 0.064 |
| SECONDARY Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) |
57.3; 34.0 | 0.0027 sig |
| SECONDARY Best Overall Response Rate (KRAS Mutant Population) |
33.8; 52.5 | 0.0290 sig |
| SECONDARY Progression-free Survival Time |
7.2; 7.2 | 0.6170 |
| SECONDARY Progression-free Survival Time (KRAS Wild-Type Population) |
8.3; 7.2 | 0.0064 sig |
| SECONDARY Progression-free Survival Time (KRAS Mutant Population) |
5.5; 8.6 | 0.0153 sig |
| SECONDARY Overall Survival Time |
18.3; 18.0 | 0.9050 |
| SECONDARY Overall Survival Time (KRAS Wild-Type Population) |
22.8; 18.5 | 0.3854 |
| SECONDARY Overall Survival Time (KRAS Mutant Population) |
13.4; 17.5 | 0.2004 |
| SECONDARY Participants With No Residual Tumor After Metastatic Surgery |
8; 4 | — |
| SECONDARY Disease Control Rate (Cut Off Date 4 August 2006) |
85.2; 81.0 | — |
| SECONDARY Duration of Response |
9.0; 5.7 | — |
| SECONDARY Safety - Number of Patients Experiencing Any Adverse Event |
170; 165 | — |
Summary
This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.
Eligibility Criteria
Inclusion Criteria
- First-line mCRC
- EGFR positive
- Bi-dimensional measurable index lesion
Exclusion Criteria
- Previous exposure to EGFR-targeting therapy
- Previous oxaliplatin-based therapy
- Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- Radiotherapy
- Surgery
- Any other investigational drug in the 30 days before randomization
- Brain metastasis and/or leptomeningeal disease
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Data sourced from ClinicalTrials.gov (NCT00125034). 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.