CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
octreotide acetate +1 moredrug
Likely dose
Octreotide acetate depot, given subcutaneouslyAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed cancer
  • ✓Malignant ascites diagnosed by treating oncologist (positive cytology not required, but patient must be symptomatic)
  • ✓Planning therapeutic paracentesis ≤3 days after study entry or completed paracentesis 2 days before study entry
  • ✓Age 18 years or older
Key exclusion· 10
  • ✕Lymphoma or lymphomatous ascites
  • ✕Known cirrhosis or portal hypertension
  • ✕Chronic renal failure (creatinine ≥2 times upper limit of normal)
  • ✕Uncontrolled diabetes mellitus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00182754
NCT00182754Phase 3Completed
CompareCT.gov

An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

Alliance for Clinical Trials in Oncology·interventional·Posted Sep 16, 2005·Updated Apr 11, 2017

In Brief

A Phase 3 clinical trial evaluating octreotide acetate and placebo for Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 33 participants across 122 sites.

Detailed Summary

RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites. PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartOct 1, 2005
Primary CompletionSep 1, 2009
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.8 years ago

Interventions

octreotide acetatedrug

Given subcutaneously

placeboother

Given subcutaneously