Clinical trial · Interventional
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)
An Asia Pacific Non-randomized, Open-label Phase II Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab (Erbitux) or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)
NCT00778830CI-TRIAL-00017913APECcompletedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cetuximab plus FOLFIRI
- interventionNames
- Drug: Cetuximab
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- Cetuximab plus FOLFOX
- interventionNames
- Drug: Cetuximab
- Drug: FOLFOX
Primary outcomes (1)
- measure
- Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)
- timeFrame
- From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)
- description
- Response rate was defined as the percentage of subjects with BORR (confirmed complete response \[CR\] or partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.