Clinical trial NCT00332696: Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Official title: Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Neoplasms
Intestinal Obstruction
Carcinomatosis
Keywords: bowel obstruction,
peritoneal carcinomatosis
Octreotide
inoperable
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Success From Day 10 to Day 13
timeFrame: Day 10 to Day 13
Secondary outcomes:
measure: Number of Participants With Treatment Success From Day 5 to Day 7
timeFrame: Day 5 to Day 7
measure: Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
timeFrame: Day 1, Day 7 and Day 14
measure: Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
timeFrame: Day 1
measure: Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
timeFrame: Day 7
measure: Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
timeFrame: Day 14
measure: Number of Participants With Relief From Obstruction at Day 7 and Day 14
timeFrame: Day 7 and Day 14
measure: Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
timeFrame: 1 Month
measure: Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
timeFrame: Month 2
measure: Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
timeFrame: Month 3
measure: Participant's Quality of Life Using the Edmonton Scale
timeFrame: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3
Other outcomes:
Locations:
city: Creteil
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: