Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Novartis

Status and phase: Completed; Phase 2

Conditions: Carcinomatosis; Peritoneal Neoplasms; Intestinal Obstruction

Treatments: Drug: Placebo; Drug: methylprednisolone; Drug: Octreotide LAR; Drug: Octreotide (Immediate release)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332696

CSMS995AFR08

Details and patient eligibility

About

To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
• Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
• No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
• No chemotherapy in the previous week;
• No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
• Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube

Exclusion criteria

• Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).

• Non authorized concomitant treatments :

  1. Anticholinergics such as scopolamine
  2. Other somatostatin analogues

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Octreotide

Experimental group

Description:

Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Treatment:

Drug: Octreotide (Immediate release)

Drug: Octreotide LAR

Drug: methylprednisolone

Placebo

Placebo Comparator group

Description:

Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Treatment:

Drug: methylprednisolone

Drug: Placebo