E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN) |
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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 | 10025960 |
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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 overall survival time in subjects receiving cetuximab in combination with cisplatin or carboplatin + 5-FU is prolonged compared to subjects receiving cisplatin or carboplatin + 5-FU only, in the first-line treatment of recurrent and/or metastatic SCCHN. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare the 2 treatment groups regarding the following: • Best overall response • Disease control • Duration of response • Time to treatment failure • Progression-free survival time • Safety • Quality of life (QoL) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• ≥18 years of age • Histologically or cytologically confirmed diagnosis of SCCHN • Recurrent and/or metastatic SCCHN, not suitable for local therapy • At least 1 bi-dimensionaly measurable lesion either by CT scan or MRI • Signed written informed consent before any study related activities are carried out • Tumor tissue available for immunohistochemical evaluation of EGFR expression • KPS of ≥70 at study entry • Effective contraception for both male and female subjects if risk of conception exists • Neutrophils ≥1500/mm³, platelet count ≥100000/mm³, and hemoglobin ≥9 g/dL • Total bilirubin ≤2 × upper limit of normality (ULN); aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) ≤3 × ULN • Creatinine clearance >60 mL/min |
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E.4 | Principal exclusion criteria |
• Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry • Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry • Nasopharyngeal carcinoma • Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV. • Uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥130 mmHg under resting conditions • Pregnancy (absence confirmed by serum β-HCG test) or lactation period • Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy • Other concomitant anticancer therapies • Documented or symptomatic brain or leptomeningeal metastasis • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insuffiency • Medical or psychological condition that would not permit the subject to complete the study or sign informed consent • Known drug abuse (with the exception of alcohol abuse) • Known allergic reaction against any of the components of the study treatment • Previous treatment with monoclonal antibody therapy, or other signal transduction inhibitors or EGFR targeting therapy • Previous or current other squamous cell carcinoma • Evidence of previous other malignancy within the last 5 years • Any investigational medication within 30 days before study entry |
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E.5 End points |
E.5.1 | Primary end point(s) |
To show superiority of the overall survival time (in months) for the cetuximab + chemotherapy group compared to the chemotherapy only group. |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of live; Pharmacogenetic effects of cetuximab |
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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 | Yes |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
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) | Yes |
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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All subjects will remain in the study until PD, unacceptable toxicity or withdrawal of consent (whichever occurs first). After the end-of-study visit, follow-up evaluations will be performed in all subjects every 3 months to collect information on further anticancer treatment and overall survival time. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |