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

• ClinicalTrials.gov Identifier: NCT00332696
• Recruitment Status: Completed
• First Posted: June 2, 2006
• Results First Posted: June 15, 2011
• Last Update Posted: September 23, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis	Drug: Octreotide LAR; Drug: Octreotide (Immediate release); Drug: methylprednisolone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
• Study Start Date: September 2005
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Treatment Success From Day 10 to Day 13 [ Time Frame: 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 :

1. Number of Participants With Treatment Success From Day 5 to Day 7 [ Time Frame: 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).
2. Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 [ Time Frame: 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.
3. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 [ Time Frame: 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.
4. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 [ Time Frame: 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.
5. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 [ Time Frame: 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.
6. Number of Participants With Relief From Obstruction at Day 7 and Day 14 [ Time Frame: 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.
7. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 [ Time Frame: 1 Month ]
   Recurrence of bowel obstruction was confirmed by abdominal X-ray.
8. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 [ Time Frame: Month 2 ]
   Recurrence of bowel obstruction was confirmed by abdominal X-ray.
9. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 [ Time Frame: Month 3 ]
   Recurrence of bowel obstruction was confirmed by abdominal X-ray.
10. Participant's Quality of Life Using the Edmonton Scale [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Novartis Investigative Site

Creteil, France

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00332696
• Other Study ID Numbers: CSMS995AFR08
• First Posted: June 2, 2006
• Results First Posted: June 15, 2011
• Last Update Posted: September 23, 2011
• Last Verified: September 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

bowel obstruction,; peritoneal carcinomatosis; Octreotide; inoperable

Additional relevant MeSH terms:

Carcinoma; Peritoneal Neoplasms; Intestinal Obstruction; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Octreotide; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists