Neoplasms

Digestive System Diseases

All Conditions

Peritoneal Neoplasms

Intestinal Obstruction

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Intestinal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Octreotide

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

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.

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.

Octreotide long-acting release (LAR) 30 mg intramuscular injection.

Octreotide LAR

Immediate-release Octreotide supplied in 100 µg/mL ampules.

Octreotide (Immediate release)

methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).

methylprednisolone

Placebo

Novartis Pharmaceuticals

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

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

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

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 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).

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and 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 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 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 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.

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

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.

Total

Age Continuous

Sex: Female, Male

Study was terminated prematurely due to low enrollment

Study Director

TREATMENT SUCCESS

Vomiting episodes <2 (per day)

Vomiting episodes ≥2 (per day)

No Nasogastric Tube since Day 10

Nasogastric Tube used since Day 10

No Anticholinergic agents

Anticholinergic agents taken

Premature discontinuation/missing data, failure

Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Number of Participants With Treatment Success From Day 10 to Day 13

Vomiting episodes <2 (per day) since Day 5

Vomiting episodes ≥2 (per day) since Day 5

No Nasogastric Tube since Day 5

Nasogastric Tube used since Day 5

Premature discontinuation/missing data

Number of Participants With Treatment Success From Day 5 to Day 7

Day 1

Day 7 (n=31,31)

Day 14 (n=28,27)

Intent-to-treat population consisted of all randomized participants who received study drug. "n" in each of the categories is the number of participants with data at the given time point.

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

Score=0

Score=1

Score=2

Score=3

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Relief from Obstruction: Day 7

No Relief from Obstruction: Day 7

Relief from Obstruction: Day 14

No Relief from Obstruction: Day 14

Number of Participants With Relief From Obstruction at Day 7 and Day 14

Recurrence at Month 1

No Recurrence at Month 1

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence at Month 2

No Recurrence at Month 2

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence at Month 3

No Recurrence at Month 3

Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Day 1 (n=30,29)

Day 7 (n=24,26)

Day 14 (n=20,14)

Month 1 (n=11,13)

Month 2 (n=7,4)

Month 3 (n=2,2)

Intent-to-treat population consisted of all participants who received at least one dose of study drug. "n" in each of the categories is the number of participants who had Quality of Life data at that time point.

Spots Global Cancer Trial Database for Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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