UI Hospitals and Clinics

Clinical Trial Details

Short Title
A multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors
Official Title

A multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors

Description

Participants in this study suffer from a disease called GEPNET (Gastro-Entero-Pancreatic Neuroendocrine-Tumor), which is a group of progressive malignant tumors. These cases have arisen from the small bowel (midgut carcinoid). Physicians have determined that the tumor/s cannot be removed completely by surgery. This study includes participants who are undergoing therapy with 20-30 mg of Octreotide LAR (Long Acting Release), a drug that should slow down progression or activity of the tumor(s). However, participants' physicians have concluded, through assessing recent CT/MRI scans (Computed Tomography/Magnetic Resonance Imaging), that the drug under the current dosing regimen is not working to prevent disease progression.

The aim of this study is to compare two treatments:

1. Peptide Receptor Radionuclide Therapy (PRRT). This is a new treatment being studied to determine the safety, efficacy and tolerability in patients with this type of cancer. This PRRT treatment is based on the administration of a radioactive product, Lutathera.

2. Octreotide LAR, 60 mg as an intramuscular injection. Participants in this study are currently taking this drug, but at a lower dose, which is considered to be the standard treatment.

The purpose for using both treatments is the same. They are both used to try and stop the disease from getting worse and perhaps to even reduce the size of tumor(s).

Start Date
February 21, 2013
End Date
February 21, 2023
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
David Bushnell, MD; Thomas O'Dorisio, MD
Contact Info

Pam Zehr, 319-353-8914

Department
Oncology
Keywords
bushnell ; cancer ; GEPNET ; IRB#201206507 ; lutathera ; octreotide LAR (Long Acting Release) ; peptide receptor radionuclide therapy (PRRT) ; phase 3 ; phase III ; small bowel (midgut carcinoid) ;

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