E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced squamous cell carcinoma of the head and neck who relapsed after a platinum containing chemotherapy or after a cisplatin-containing chemoradiotherapy are eligible for this study. |
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MedDRA Classification |
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 |
The primary objective is the objective response rate (CR + PR) according to the RECIST criteria to cetuximab in combination with docetaxel for the treatment of relapsed head and neck carcinoma: A clinical phase II trial |
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E.2.2 | Secondary objectives of the trial |
• Response rate in relation to cisplatin sensitivity • Time to progression • Overall survival • Quality of life (EORTC QLQ C-30) • Safety profile of cetuximab in combination with docetaxel in patients with head and neck cancer
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed written informed consent • Male or female > 18 years of age • Histologically confirmed recurrent or metastatic stage III/IV squamous cell carcinoma of the head and neck • Relapse after cisplatin containing chemoradiotherapy or Relapse after platinum containing 1st-line chemotherapy • No intercurrent anticancer treatment since platinum-failure • At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present • ECOG Performance Status 0-1 • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 80 x 109/L, hemoglobin > 10.0 g/dL • Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, AP, -GT < 3 x ULN • Adequate renal function: serum creatinine < 1.5 mg/dL • If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
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E.4 | Principal exclusion criteria |
• Prior treatment with docetaxel • Prior exposure to EGFR pathway targeting therapy • Other serious illness or medical conditions: - Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4; - Significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; • Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass • Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease. • Having participated in another clinical trial or having received any investigational agent in the preceding 30 days • Known allergic/hypersensitivity reaction to any of the components of the treatment • Pregnancy (absence confirmed by serum/urine -HCG) or breast-feeding • Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix • Legal incapacity or limited legal capacity • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary target variable is the objective response rate (CR+PR) according to the RECIST criteria. |
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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 | 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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | 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 | No |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 planned cetuximab treatment duration per patient is until progression of disease, whereas doxetaxel will be discontinued after a maximum of 6 cycles (18 infusions). The end of study is defined as the last follow-up visit (2 years after end of treatment) of the last patient. Treatment period end date: Q3, 2008 |
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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 | 10 |
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 | 10 |