Antitumor Efficacy Of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized Vs Sunitinib In Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-07-20
First Submitted that Met QC Criteria 2014-08-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-07-23
First Posted (ACTUAL) 2014-09-03	Results First Posted N/A	Last Verified 2018-07

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 177Lu-DOTA0-Tyr3-Octreotate or OCLU 7.4 GBq per injection (max: 4 injections)	DRUG: 177Lu-DOTA0-Tyr3-Octreotate
ACTIVE_COMPARATOR: Sunitinib 37.5 mg/day	DRUG: Sunitinib

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 177Lu-DOTA0-Tyr3-Octreotate or OCLU

7.4 GBq per injection (max: 4 injections)

DRUG: 177Lu-DOTA0-Tyr3-Octreotate

ACTIVE_COMPARATOR: Sunitinib

37.5 mg/day

DRUG: Sunitinib

Primary Outcome Measures	Measure Description	Time Frame
To determine the 12 months PFS		Assessed 12 months after randomization

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival		Assessed every 3 months until death
Best response	According to RECIST V1.1	Assessed every 12 weeks until progression up to 48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically proven and reviewed well differentiated malignant pancreatic sporadic NET Metastatic disease not amenable to surgical resection
All target lesions (lesions measurable and non-measurable according to the RECIST 1.1 criteria), of a size ≥ 15 mm, twice the spatial resolution of the somatostatin receptor scintigraphy (SRS), should be positive (grade of uptake at SRS≥ 2, equal to the physiologic liver uptake) within 24 weeks prior to enrollement. Negative target lesions are acceptable if below 15mm.
Post first line whatever the type of systemic therapy: cytotoxic chemotherapy or everolimus or somatostatine analogs... Only one line of cytotoxic chemotherapy is authorized.
Evaluable disease according to RECIST 1.1 criteria (Appendix 2)
Progressing disease within 12 months prior to randomization according to RECIST 1.1 criteria ;
ECOG performance status 0-2 (appendix 9)
Life expectancy ≥ 6 months as prognosticated by the physician
Age ≥ 18 years, no superior limit
Adequate bone marrow reserve (Hb > 8, neutrophils ≥ 1500/mm³ and platelets ≥80.000/mm^3)
Effective contraception in pre-menopausal female and male patients during and for at least 6 months post-treatment.
Patient´s signed written informed consent
Ability to comply with the protocol procedures
Ability to take oral medication
Patient affiliated to a social security system or beneficiary of the same.

Large or small cell-poorly differentiated pancreatic neuroendocrine tumor according to WHO 2010 classification
Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless OctreoScan® imaging during continued Octreotide treatment is in accordance with the inclusion criteria n°2.
More than one line of cytotoxic chemotherapy (a patient who received the same molecules of cytotoxic chemotherapy at several times during therapeutic management is considered to have benefit from one single line of cytotoxic chemotherapy)
Prior external beam radiation therapy to more than 25% of the bone marrow
Urinary incontinence
History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least five years.
Severe renal (measured GFR according to MDRD <50ml/mn or nephrotic syndrome) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN
Decompensated heart failure (ejection fraction <45%), myocardial infarction, stroke, pulmonary embolism or revascularization procedure,unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.
Hypertension that cannot be controlled despite medications (>=160/95 mmHg despite optimal medical therapy)
Abnormal cardiac function with 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for males or >480 msec for females.
Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CTscan with contrast or MRI to document stable disease prior to enrolment in the study.)
Pregnancy or breast feeding (see appendix 6)
Previous treatment with the drugs under study. Prior systemic treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors.
Current treatment with another investigational drug.
Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
Prior treatments with chemotherapy or immunotherapy or somatostatine analog therapy drug (except in case of functioning syndrome for somatostatine analogue therapy) or thoracic radiotherapy within 4 weeks prior to start of treatment
Major surgery for any cause or local radiotherapy within one month prior to start of treatment
Liver embolisation therapy within the last 3 months prior start of treatment except if progression is demonstrated and embolised lesion not used as targets
Unrecovered toxicity from any kind of therapy
Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration,or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Collaborators and Investigators

Publications

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Caregivers

Clinical Trial Record