Phase 2
N=289
Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)
Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00778830 ↗Enrolled (actual)
289
Serious AEs
34.9%
Results posted
May 2015
Primary outcome: Primary: Percentage of Subjects With Best Overall Confirmed Response Rate (BORR) — 54.5; 61.2 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); FOLFIRI (Drug); FOLFOX (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Best Overall Confirmed Response Rate (BORR) |
54.5; 61.2 | — |
| SECONDARY Progression-Free Survival (PFS) Time |
11.1; 11.1 | — |
| SECONDARY Overall Survival (OS) Time |
26.6; 27.0 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death |
99; 180; 37; 64; 5; 10 | — |
Summary
This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid + fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil + oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.
Eligibility Criteria
Inclusion Criteria
Signed written informed consent
- Inpatient or outpatient subjects, 18 years of age
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease (M1)
- Life expectancy of at least 12 weeks
- Presence of at least 1 measurable index lesion (not lie in an irradiated area) by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry
- Effective contraception for both male and female subjects if the risk of conception exists
- White blood cell count greater than or equal to (>=) 3,000 per cubic millimeter (/mm^3) with neutrophils >=1,500/mm3, platelet count >=100,000/mm3, hemoglobin >=5.6 millimole per liter (mmol/L) (9 gram per deciliter [g/dL])
- Total bilirubin less than or equal to ( 6 months before the start of treatment in this study
- Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
- Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor (VEGF) therapy, or epidermal growth factor receptor (EGFR-) pathway targeting therapy not indicated in this study protocol
- Concurrent hormone therapy not indicated in this study protocol except for physiologic replacement or contraception
- Known hypersensitivity reaction to any of the components of study treatments
- Pregnancy (absence to be confirmed by beta human choriongonadotrophin [beta-hCG] test) or lactation period
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Peripheral neuropathy > grade 1
- Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- Known alcohol or drug abuse
- Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
- Participation in another clinical study within the past 30 days
- Significant disease which, in the investigator's opinion, would exclude the patient from the study
- Legal incapacity or limited legal capacity
- KRAS mutated status of tumor tissue
Data sourced from ClinicalTrials.gov (NCT00778830). 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.