Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 1,499
- Locations
- 1
- Primary Endpoint
- Response
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DOTA-TOC
Treatment arm
Intervention: DOTA-TOC Treatment (Drug)
Outcomes
Primary Outcomes
Response
Time Frame: 3 months
Secondary Outcomes
- Toxicity(3 months)
- Survival(life-long)