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)

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Pte. Ltd., Singapore
• Treatments: Cetuximab

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 (<=) 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