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

NCT00332696 | Completed Phase 2 Results

• 1 other identifier: CSMS995AFR08
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis

Keywords

bowel obstruction,; peritoneal carcinomatosis; Octreotide; inoperable

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

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

  Day 5 to Day 7

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

  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

  Day 1

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

  Day 7

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

  Day 14

Study Arms (2)

Octreotide

EXPERIMENTAL

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; Drug: Octreotide (Immediate release); Drug: methylprednisolone

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Octreotide LAR DRUG

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

Also known as: Sandostatin® LAR

Octreotide

Octreotide (Immediate release) DRUG

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

Also known as: Sandostatin®

Octreotide

methylprednisolone DRUG

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

Octreotide; Placebo

Placebo DRUG

Physiologic saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube

You may not qualify if:

• Abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/L).
• Non authorized concomitant treatments :
• Anticholinergics such as scopolamine
• Other somatostatin analogues

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Créteil, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Intestinal Obstruction; Carcinoma

Interventions

Octreotide; Methylprednisolone

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Limitations and Caveats

Study was terminated prematurely due to low enrollment

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: September 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 23, 2011
• Results First Posted: June 15, 2011

Record last verified: 2011-09

Locations

FR (1)