DOTA-TOC in Metastasized Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978211
• Other study ID #: MAW002
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2009
• Last updated: August 5, 2015
• Start date: September 1997
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public HealthSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1499
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• DOTA-TOC Treatment
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.

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Iten F, Muller B, Schindler C, Rasch H, Rochlitz C, Oertli D, Maecke HR, Muller-Brand J, Walter MA. [(90)Yttrium-DOTA]-TOC response is associated with survival benefit in iodine-refractory thyroid cancer: long-term results of a phase 2 clinical trial. Cancer. 2009 May 15;115(10):2052-62. doi: 10.1002/cncr.24272. — View Citation

Iten F, Müller B, Schindler C, Rochlitz C, Oertli D, Mäcke HR, Müller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. — View Citation

Otte A, Mueller-Brand J, Dellas S, Nitzsche EU, Herrmann R, Maecke HR. Yttrium-90-labelled somatostatin-analogue for cancer treatment. Lancet. 1998 Feb 7;351(9100):417-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response		3 months	No
Secondary	Toxicity		3 months	Yes
Secondary	Survival		life-long	No