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

Peritoneal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332696
• Other study ID #: CSMS995AFR08
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2006
• Last updated: September 20, 2011
• Start date: September 2005
• Est. completion date: September 2008

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinomatosis
• Intestinal Obstruction
• Peritoneal Neoplasms

Intervention

Drug:
• Octreotide LAR
Octreotide long-acting release (LAR) 30 mg intramuscular injection.
• Octreotide (Immediate release)
Immediate-release Octreotide supplied in 100 µg/mL ampules.
• methylprednisolone
methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
• Placebo
Physiologic saline solution

Locations

Country	Name	City	State
France	Novartis Investigative Site	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No