DOTA-TOC in Metastasized Neuroendocrine Tumors

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: DOTA-TOC Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00978211

MAW002

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,499 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,499 participants in 1 patient group

DOTA-TOC

Experimental group

Description:

Treatment arm

Treatment:

Drug: DOTA-TOC Treatment