E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic colon rectal carcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess whether the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab is superior to 5-FU/FA plus oxaliplatin as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer. |
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E.2.2 | Secondary objectives of the trial |
To compare the 2 treatment groups regarding the following: Curative metastatic surgery Duration of response Disease control rate Progression-free survival time Overall survival time Safety and to perform a population pharmacokinetic analysis |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· Signed written informed consents (first and second) · Inpatient or outpatient ≥18 years of age · Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum · 1st occurrence of metastatic disease (not curatively resectable) · Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue · Life expectancy of at least 12 weeks · Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area) · ECOG performance status of ≤ 2 at study entry · Effective contraception for both male and female subjects if the risk of conception exists · White blood cell count (WBC) ≥ 3x109/L with neutrophils ≥1.5x109/L, platelet count > 100x109/L, hemoglobin ≥ 6.21 mmol/L (10 g/dL) · ASAT and ALAT ≤ 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 |
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E.4 | Principal exclusion criteria |
· Previous exposure to epidermal growth factor receptor-targeting therapy· Previous oxaliplatin-based chemotherapy · Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment · Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before randomization · Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except for physiologic replacement · Known hypersensitivity reaction to any of the components of study treatments · Pregnancy (absence to be confirmed by β 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 · Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix · Known alcohol or drug abuse· Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent· Participation in another clinical study within the 30 days before randomization · Significant disease which, in the investigator’s opinion, would exclude the subject from the study · Peripheral neuropathy > grade 1 · Legal incapacity or limited legal capacity |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is defined as the moment all subjects have performed the first 3-monthly Follow-Up visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |