A Multicenter Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

NCT01456078 | Completed Phase 2

• 1 other identifier: EudraCT number: 2011-000240-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

By improved kidney dosimetry including biological effective dose and taking into account potential risk factors (especially for kidney toxicity), it might be possible to give an optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic neuroendocrine tumor.

Conditions

Neuroendocrine Tumors; Liver Metastases

Keywords

Neuroendocrine tumor; Liver metastases; 177Lu-DOTA-TATE; Safety; Kidney dosimetry; Dose escalation; Neuroendocrine tumors, with liver metastases.

Outcome Measures

Primary Outcomes (1)

• Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy

  3 months after completed step 1

Secondary Outcomes (1)

• Objective tumor response after receiving a cumulative BED to the kidneys of 40 +/- 2 Gy as per RECIST v 1.1

  3 months after completing step 2 treatment

Study Arms (1)

177Lu-DOTA-TATE

EXPERIMENTAL

Drug: 177Lu-DOTA-TATE

Interventions

177Lu-DOTA-TATE DRUG

177Lu-DOTA-TATE given as intravenous infusion given during 3-5 treatments. Evaluation is performed after every single cycle. Further more, evaluation is made after last cycle, and delivered cumulative dose to kidneys should be 27 Gy. Patients with stable disease or partial response, and without pronounced toxicity will continue treatment to a step 2, where additional 3-5 treatment cycles are given, with a cumulative dose to kidneys to 40 Gy.

177Lu-DOTA-TATE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Step 1:
• ECOG 0-2
• Histologically verified neuroendocrine tumors with a Ki67 of at least 20 % or at least 20 mitoses/high power fields. If the tissue on which this determination is based is several years old, the investigator should consider the option of acquiring a new determination, especially if the behaviour of the tumor has changed since diagnosis
• Metastatic disease where complete resection is not considered possible or feasible
• Measurable disease
• Radiological disease progression during the last 14 months
• The largest metastases should have an uptake of 111In-octreotide that is greater than the uptake in the liver by planar scintigraphy. Metastases that are small, or located centrally, can be evaluated by SPECT to enable a correct estimation of the relative uptake. The majority of the tumor burden must demonstrate an increased uptake for lutetium-treatment to be considered
• Stable dose of somatostatin analogue for the past 3 months
• Estimated survival more than 6 months
• ANC more than 1.5 x 10 9/L
• Bilirubin less than 1.5 x upper limit of normal
• GFR more than 50 ml/min.
• Signed written informed concent
• Step 2:

You may not qualify if:

• A maintained GFR (less than 40 % decrease compared to baseline AND GFR more than 50 ml/min)
• The treatment in step 1 have been administered with a maximal interval of 12 weeks
• Age under 70 years
• Step 1:
• Performance Status ECOG 3-4
• Proliferation index (Ki67) more than 20 % or more than 20 mitoses/hpf
• Loco-regional treatment during the last 3 months involving all of the measurable lesions
• Chemotherapy during the last 3 months, or longer if persisting toxicity exists. Earlier treatment with mTORi or TKI is permitted
• Other concommitant nephrotoxic treatment
• Modifications of the somatostatine dose in the last 3 months
• Serious heart disease
• Previous radiotherapy including more than 25 % of active bone marrow volume
• Pregnancy and lactation
• Extensive liver metastases (more than 50 % of liver volume)
• Symptomatic CNS metastases requiring corticosteroid treatment

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (2)

Sahlgrenska University Hospital, Department of Oncology

Gothenburg, 413 45, Sweden

Location

Department of Oncology, Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

• Sundlov A, Gleisner KS, Tennvall J, Ljungberg M, Warfvinge CF, Holgersson K, Hallqvist A, Bernhardt P, Svensson J. Phase II trial demonstrates the efficacy and safety of individualized, dosimetry-based 177Lu-DOTATATE treatment of NET patients. Eur J Nucl Med Mol Imaging. 2022 Sep;49(11):3830-3840. doi: 10.1007/s00259-022-05786-w. Epub 2022 Apr 22.

  PMID: 35451612 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Jan Tennvall, MD, PhD

  Department of Oncology, Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

SE (2)