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)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Cetuximab

Drug: FOLFOX

Drug: FOLFIRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00778830

EMR 62202-505

Details and patient eligibility

About

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.

Enrollment

289 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 (<=) 1.5 x upper reference range
Aspartate aminotransferase (AST) <=2.5 x upper reference range, or <=5 x upper reference range in case of liver metastasis
Serum creatinine <=1.5 x upper reference range
Recovery from relevant toxicity to previous treatment before study entry
KRAS wild-type status of tumor tissue

Exclusion criteria

Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated >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