Clinical trial NCT03083210: Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET
Official title: PILOT STUDY OF LANREOTIDE IN METASTATIC OR RECURRENT GRADE I-II HINDGUT NET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neuroendocrine Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
Primary purpose: TREATMENT

Brief summary: Clinical data from uncontrolled retrospective or prospective studies have initially demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET patients, this is based on the results of CLARINET study, the largest prospective trial to evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries) with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67. The study had shown that treatment with lanreotide Autogel® significantly prolonged progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the primary analysis (median progression-free survival, not reached vs. 18.0 months, P\< 0.001 by the stratified log-rank test; hazard ratio for progression or death with lanreotide vs. placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) \[5\].

The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease. The addition of an indication for the treatment of patients with GEP-NETs has been approved by more than 15 other authorities including in Canada, Australia and some Asian countries, etc.

Detailed description: Patients with advanced hindgut NET who don't receive prior systemic therapies will receive laneotide. Study-arm is composed of 28 patients. Laneotide 120mg s.c. once every a 28 day.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed well differentiated or moderate differentiated neuroendocrine tumor. WHO 2010 Grade 1 or 2
* Age \>20
* Measurable disease by RECIST v 1.0
* Primary tumor were located in hindgut, colorectal areas.
* Non functioning or functioning NETs
* Unresectable locally advanced or metastatic disease

Exclusion Criteria:

* Prior receiving systemic therapies including interferon, chemotherapy, PRRT, chemoembolization or a somatostatin analogue at any time (unless they had received it \>6 months previously and for \<15 days).
* Multiple endocrine neoplasia
* Previous cancer except in the case of patients with treated or untreated in situ cervical or uterine carcinoma or basal cell skin cancer or patients with other cancers who had been treated with curative intent and had been disease free for \> 5 years
* Foregut, midgut, and pancreatic NETs and NETs of unknown primary origin Cross reference: Hindgut: Distal 1/3rd transverse colon, descending colon, sigmoid colon, rectum, upper anal canal

Primary outcomes:
measure: Progression free survival
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Youngsuk Park
Study officials:
References: