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

Phase 2

Completed

Conditions: Peritoneal Neoplasms
Intestinal Obstruction
Carcinomatosis

Interventions: Drug: Octreotide LAR
Drug: Placebo
Drug: Octreotide (Immediate release)
Drug: methylprednisolone

Registration Number: NCT00332696

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide	methylprednisolone	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.
Placebo	methylprednisolone	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.
Placebo	Placebo	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.
Octreotide	Octreotide LAR	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.
Octreotide	Octreotide (Immediate release)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Success From Day 10 to Day 13	Day 10 to Day 13	Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7	Day 7	Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14	Day 14	Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.
Number of Participants With Relief From Obstruction at Day 7 and Day 14	Day 7 and Day 14	Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.
Participant's Quality of Life Using the Edmonton Scale	Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3	The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.
Number of Participants With Treatment Success From Day 5 to Day 7	Day 5 to Day 7	Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14	Day 1, Day 7 and Day 14	The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1	Day 1	Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1	1 Month	Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2	Month 2	Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3	Month 3	Recurrence of bowel obstruction was confirmed by abdominal X-ray.