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

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Conditions
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Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis

Intervention / Treatment
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* Drug: Octreotide LAR
* Drug: Octreotide (Immediate release)
* Drug: methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 : Anticholinergics such as scopolamine Other somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide<br>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. | Drug: Octreotide LAR<br>* Octreotide long-acting release (LAR) 30 mg intramuscular injection.<br>* Other names: Sandostatin® LAR;Drug: Octreotide (Immediate release)<br>* Immediate-release Octreotide supplied in 100 µg/mL ampules.<br>* Other names: Sandostatin®;Drug: methylprednisolone<br>* methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).<br>|
| Placebo Comparator: Placebo<br>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. | Drug: methylprednisolone<br>* methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).<br>Drug: Placebo<br>* Physiologic saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Success From 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. | Day 10 to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Success From 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). | Day 5 to Day 7 | 
| Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. | 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 | 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. | Day 1 | 
| Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at 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. | Day 7 | 
| Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at 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. | Day 14 | 
| Number of Participants With Relief From Obstruction at 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. | Day 7 and Day 14 | 
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | Recurrence of bowel obstruction was confirmed by abdominal X-ray. | 1 Month | 
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | Recurrence of bowel obstruction was confirmed by abdominal X-ray. | Month 2 | 
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | Recurrence of bowel obstruction was confirmed by abdominal X-ray. | Month 3 | 
| Participant's Quality of Life Using the Edmonton Scale | 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. | Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable