Overview

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

Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lund University Hospital
Treatments:
Lutetium Lu 177 dotatate
Octreotide
Criteria
Inclusion Criteria:

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:

- Continues to fulfill all of the inclusion criteria, and none of the exclusion
criteria, from step 1

- 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

Exclusion Criteria:

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

- Ongoing treatment with interferon. This treatment should be suspended a minimum of 4
weeks before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs of
toxicity

- Patients who have another metastatic tumor diagnosis

Step 2:

- Progressive disease since start of study treatment

- Organ toxicity grade 3-4 during step 1

- Serious hematological toxicity during previous treatment cycles (ANC less than 0.5 x
10 9 or platelets less than 50.0 x 10 9)

- Longstanding diabetes (more than 8 years). Patients with a well-controlled diabetes
with a history of less than 8 years and a blood pressure less than 130/80 and no
albuminuria (albumin/creatinine index)can be included

- Hypertension, i.e. more than 160/90 (for diabetics more than 130/80). Antihypertensive
pharmacological treatment is permitted as long as there is no manifest albuminuria

- Previous liver embolisation

- Previous chemotherapy