E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim is to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0-resectable pancreatic cancer and to evaluate if the progression free survival can be increased by the addition of an EGFR-targeted therapy.
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033609 |
E.1.2 | Term | Pancreatic carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The primary study objective is to determine the disease-free survival rate at 18 months after start of treatment. Disease-free survival time is defined as the time from start of registration to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last documented efficacy documentation. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the following parameters:
• Overall survival • treatment related toxicity • Quality of life
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Yes, there is one side project, titeled: "Einfluss des Ras-Signalwegs auf das Therapieansprechen" Aim of the side project is to detect the K-Ras staus of the ATIP patients; |
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E.3 | Principal inclusion criteria |
• Provided signed written informed consent. • Men and woman age >= 18 years • Histologically confirmed R0 or R1 resected ductal adenocarcinoma of the pancreas • Life expectancy >12 weeks • Patients with ECOG performance status <= 2 • Patients without metastasis
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E.4 | Principal exclusion criteria |
• Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study. • Women who are pregnant or breastfeeding. • Women with a positive pregnancy test on enrolment or prior to study drug administration. • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial). • Inadequate hematologic function defined by an absolute neutrophils count (ANC) < 1,500/mm³, a platelet count < 100,000/mm³ and a hemoglobin < 9 g/dL. • Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels > 5 times the ULN. • Serum bilirubine > 1.5 times the ULN. • Inadequate renal function defined by a serum creatinine > 1.5 times the ULN. • Prior cetuximab or other therapy which targets the EGF pathway. • Prior antibody therapy. • Any known allergic reaction against cetuximab. • Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents. • HIV infection. • Having participated in another clinical trial in the preceding 30 days.
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the effects of treatment with cetuximab and gemcitabine on disease-free-survival in patients with R0 or R1-resected adenocarcinoma of the pancreas (adjuvant therapy setting) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Overall survival • Quality of life • Incidence of Adverse Events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |