DOTA-TOC in Metastasized Neuroendocrine Cancer
Conditions
Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Conditions: Keywords
DOTATOC, somatostatin, radiopeptide, Yttrium, Lutetium, neuroendocrine, cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DOTA-TOC Treatment
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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)

Exclusion Criteria:

- concurrent anti-tumor treatment

- secondary malignancies

- pregnancy

- breast-feeding

- incontinence

- severe concomitant illness including severe psychiatric disorders
Location
University Hospital
Basel, BS, Switzerland
Status: Recruiting
Contact: Martin A. Walter, MD - m.a.walter@gmx.net
Start Date
September 1997
Completion Date
May 2014
Sponsors
University Hospital, Basel, Switzerland
Source
University Hospital, Basel, Switzerland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page