DOTA-TOC in Metastasized Neuroendocrine Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00978211
First received: September 15, 2009
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Tumors
Drug: DOTA-TOC Treatment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: life-long ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: September 1997
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DOTA-TOC
Treatment arm
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.
Other Names:
  • tetraazacyclododecanetetraacetic acid (DOTA) modified
  • somatostatin analog Tyr3-octreotide (TOC)

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978211

Locations
Switzerland
University Hospital Recruiting
Basel, BS, Switzerland, 4031
Contact: Martin A. Walter, MD       m.a.walter@gmx.net   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Martin A Walter, MD Institute of Nuclear Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin A. Walter, Attending Physician, Institute of Nuclear Medicine, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00978211     History of Changes
Other Study ID Numbers: MAW002
Study First Received: September 15, 2009
Last Updated: November 2, 2011
Health Authority: Switzerland: Federal Office of Public Health
Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
DOTATOC
somatostatin
radiopeptide
Yttrium
Lutetium
neuroendocrine
cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neoplastic Processes
Neoplasms
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Somatostatin
Edotreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014