DOTA-TOC in Metastasized Neuroendocrine Tumors

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: DOTA-TOC Treatment

• Registration Number: NCT00978211
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Study Timeline

• Study Start: 1997-09
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1499

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)

Exclusion Criteria

• concurrent anti-tumor treatment
• secondary malignancies
• pregnancy
• breast-feeding
• incontinence
• severe concomitant illness including severe psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DOTA-TOC	DOTA-TOC Treatment	Treatment arm

Primary Outcome Measures

Name	Time	Method
Response	3 months

Secondary Outcome Measures

Name	Time	Method
Toxicity	3 months
Survival	life-long

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, BS, Switzerland