Octreotide in Treating Patients With Cancer-Related Malignant Ascites

What Was Tested

This registered phase 3 trial tested Octreotide.

It had two arms (groups): Arm I (experimental) and Arm II (placebo comparator).

Patients receive octreotide subcutaneously (SC) once on day 1.

Patients receive placebo SC once on day 1.

The registry classes the interventions as drug and other.

More on the Plan

Secondary * Compare the number of paracenteses in patients treated with these drugs. * Determine the toxicity of octreotide in these patients. * Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other).

Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive octreotide subcutaneously (SC) once on day 1. * Arm II: Patients receive placebo SC once on day 1.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of malignant ascites, as determined by the treating oncologist. Positive cytology not required. Patient is symptomatic and views ascites as a problem. No lymphoma or lymphomatous ascites. Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry.

The full record lists 30 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2005-10 with completion listed for 2009-09.

It ran at 122 sites in United States (122).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Median Time to Paracentesis (time frame: Up to 2 years).

It also tracked 2 secondary outcomes, for example Number of Paracenteses and Average Quality-of-life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.