DOTA-TOC in Metastasized Neuroendocrine Tumors

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: DOTA-TOC Treatment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DOTA-TOC<br>Treatment arm | Drug: DOTA-TOC Treatment<br>* Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of renal toxicity loss of patient transferability or denial of further treatment.<br>* Other names: somatostatin analog Tyr3-octreotide (TOC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 3 months | 
| Survival |  | life-long | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DOTATOC, somatostatin, radiopeptide, Yttrium, Lutetium, neuroendocrine, cancer