Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

Ipsen

Status and phase: Completed; Phase 3

Conditions: Peritoneal Neoplasms; Carcinoma; Intestinal Obstruction

Treatments: Drug: Lanreotide (microparticle formulation); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00216372

2-54-52030-156 (408)

2005-002349-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• digestive obstruction located in the upper part of the gastro-intestinal tract
• digestive obstruction of malignant origin
• peritoneal carcinomatosis confirmed by a CT Scan
• at least two vomiting episodes per day or a presence of a nasogastric suction tube
• inoperable patients

Exclusion criteria

• specific anticancer therapy within the previous 15 days
• signs of bowel perforation
• somatostatin or any analogue as treatment of the bowel obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Lanreotide (microparticle formulation)

2

Placebo Comparator group

Treatment:

Other: Placebo