E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastasizing ileal/coecal carcinoids (WHO ICD-10 code: C17.9) |
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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 |
To assess the efectivness of two PegIntron doses (0.8ug/kg and 1.6 ug/kg) in inducing a tumour response during 6 months treatment, defined as a reduction of 50% in 5-HIAA, and/or in serum chromagranin A, and /or in tumour size, in patients with metastasizing ileal/coecal carcinoids |
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E.2.2 | Secondary objectives of the trial |
a) To assess the effectiveness of the PegIntron doses actually used i.e. incorporating possible dose reduction (0.4, 0.8, 1.2 and 1.6 ug/kg), in inducing a tumour response during 6 months treatment, defined as a reduction of 50% in 5-HIAA, and/or in serum chromogranin A, and/or in tumour size, in patients with metastasizing ileal/coecal carcinoids
b) To compare the tolerability between two PegInron doses (0.8 ug/kg and 1.6 ug/kg) at 6 months follow up.
c) To compare the difference in patient quality of life in two PegIntron dose groups (0.8 ug/kg and 1.6 ug/kg) by EORTC QLQ-C30 version 3.0 after 6 months treatment.
d) To investigate the safety of two PegIntron doses (0.8 ug/kg and 1.6 ug/kg) during 6 months treatment.
e) To evaluate the effectiveness of two PegIntron doses (0.8 ug/kg and 1.6 ug/kg) with respect to relief of symptoms related to the carcinoid syndrome.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients suffering from metstasizing, histopathologically verified (chromogranin A and serotonin immunohistochemistry must be positive), highly differentiated NE carcinomas of the jejunum/ileum/valvula Bauhini and the adjacent parts of coecum/colon ascendens. Patients with NE carcinomas of the duodenum, the appendix (including also goblet-cell carcinoids) are not included, neither those with poorly differentiated NE carcinomas (proliferation index higher than 15 %)
Measurable disease as diagnosed by means of CT or MRI according to the RECIST criteria
U-5-HIAA > 2 x upper normal limit and/or P-Chromogranin A > 2 x upper normal limit
Age >18 years.
Life expectancy of more than 12 months
Patients must be willing to give written informed consent
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E.4 | Principal exclusion criteria |
Previous or present interferon treatment
Previous radioactive tumour-targeting treatment
Other active or previous neoplasms within 5 years (except non-melanoma skin cancer or in situ cervical cancer)
Liver embolization or radiofrequency ablation within 3 months prior to screening
Patients who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease
Contraindications to the investigational product, e.g. known or suspected hypersensitivity
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the tumour responses after 6 months treatment or at withdrawal. The patients are grouped to the doses, which they are randomized to. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | No |
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 | 2 |
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 | 2 |