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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00332696
First received: June 1, 2006
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Peritoneal Neoplasms
Intestinal Obstruction
Carcinomatosis
Drug: Octreotide LAR
Drug: Octreotide (Immediate release)
Drug: methylprednisolone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Treatment Success From Day 10 to Day 13 [ Time Frame: Day 10 to Day 13 ] [ Designated as safety issue: No ]

    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:
  • Number of Participants With Treatment Success From Day 5 to Day 7 [ Time Frame: Day 5 to Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, Day 7 and Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 7 and Day 14 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Recurrence of bowel obstruction was confirmed by abdominal X-ray.

  • Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    Recurrence of bowel obstruction was confirmed by abdominal X-ray.

  • Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Recurrence of bowel obstruction was confirmed by abdominal X-ray.

  • Participant's Quality of Life Using the Edmonton Scale [ Time Frame: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 64
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332696

Locations
France
Novartis Investigative Site
Creteil, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00332696     History of Changes
Other Study ID Numbers: CSMS995AFR08
Study First Received: June 1, 2006
Results First Received: January 17, 2011
Last Updated: September 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
bowel obstruction,
peritoneal carcinomatosis
Octreotide
inoperable

Additional relevant MeSH terms:
Neoplasms
Intestinal Obstruction
Peritoneal Neoplasms
Carcinoma
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Peritoneal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Octreotide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 26, 2014