Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide.

It had two arms (groups): Octreotide Long Acting Release (experimental) and Standard Treatment (other).

Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.

The registry classes the interventions as drug and other.

More on the Plan

Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen containing fluorouracil, capecitabine and/or irinotecan.

Eligible chemotherapy regimens include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin, Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin, Bevacizumab or Cetuximab.

Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal Growth Factor Receptor (EGFR)-inhibitors, will not be eligible.

The acute treatment for diarrhea will be left to physician's discretion in both groups.

Who Took Part

The registry lists 139 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Providing a written informed consent. Age between 18 and 80 years;. Indication of treatment, according to the judgment of the investigator, with a chemotherapy regimen containing either 5-FU, capecitabine, or irinotecan; any such regimen may also include oxaliplatin, bevacizumab, or cetuximab;. A performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. Adequate organ function and lab values within specific ranges.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: use of concomitant antineoplastic treatments, other than regimens containing either 5-fu, capecitabine, or irinotecan with or without oxaliplatin, bevacizumab, or cetuximab;; previous or concomitant need for radiotherapy to the abdomen or pelvis;; indication of treatment, according to the judgment of the investigator, with erlotinib, gefitinib, panitumumab, or other egfr-inhibitors other than cetuximab;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2008-04 with completion listed for 2010-09.

It ran at 11 sites in Brazil (11).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants Developing Diarrhea (Grade 1 to 4) (time frame: 6 month overall).

It also tracked 10 secondary outcomes, for example Number of Episodes of Diarrhea by Patient, Number of Episodes of Diarrhea by Patient by Cycle, Percentage of Patients by Grade of Diarrhea, Percentage of Episodes by Grade, Percentage of Participants Who Need Opioids for Control of Diarrhea and Percentage of Patients Hospitalized Due to Diarrhea.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 139 people.

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.