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


Phase 2
N/A
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Martin A Walter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Nuclear Medicine

Authority:

Switzerland: Federal Office of Public Health

Study ID:

MAW002

NCT ID:

NCT00978211

Start Date:

September 1997

Completion Date:

May 2014

Related Keywords:

  • Neuroendocrine Tumors
  • DOTATOC
  • somatostatin
  • radiopeptide
  • Yttrium
  • Lutetium
  • neuroendocrine
  • cancer
  • Neoplasm Metastasis
  • Neuroendocrine Tumors

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