Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors

University Hospital, Basel, Switzerland1 site in 1 country1,499 target enrollmentSeptember 1997

ConditionsNeuroendocrine Tumors

InterventionsDOTA-TOC Treatment

DrugsDOTA-TOC Treatment

Overview

Phase: Phase 2
Intervention: DOTA-TOC Treatment
Conditions: Neuroendocrine Tumors
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 1499
Locations: 1
Primary Endpoint: Response
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators aim to explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic [90Y-DOTA]-TOC and [177LuDOTA]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Detailed Description

Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). \[90Y-DOTA\]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009). Study Aim: To explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival. Study Type: Clinical phase II, single-center, open-label trial Patients: 1500 patients

Registry

clinicaltrials.gov

Start Date

September 1997

End Date

December 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•histologically confirmed neuroendocrine cancer
•stage IVc disease by definition of the American Joint Committee on Cancer, i.e. occurrence of distant metastases
•visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111In-Octreoscan)