Prospective study of patients treated with pegylated interferon-alpha 2b (PegIntron) for metastasizing ileal/coecal carcinoids - NA

• Conditions: Metastasizing ileal/coecal carcinoids (WHO ICD-10 code: C17.9)

• Registration Number: EUCTR2006-002275-40-SE
• Lead Sponsor: ppsala University Hospital, Dept. of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-05
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified