Metastasizing ileal/coecal carcinoids (WHO ICD-10 code: C17.9)
Conditions
Interventions
Trade Name: PegIntron
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Peginterferon alfa-2b
Current Sponsor code: SCH54031
Other descriptive name: PEG-intron
Co
Sponsors
Uppsala University Hospital, Dept. of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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. ;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. | — |
Countries
Denmark, Sweden
Outcome results
None listed