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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 (OCCLURANDOM)

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ClinicalTrials.gov Identifier: NCT02230176
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : July 23, 2018
National Cancer Institute, France
Advanced Accelerator Applications
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Carcinoma Drug: Sunitinib Drug: 177Lu-DOTA0-Tyr3-Octreotate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2015
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

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 :
  1. To determine the 12 months PFS [ Time Frame: Assessed 12 months after randomization ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230176

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Contact: Eric BAUDIN, MD, PhD 0142114244 ext +33 eric.baudin@gustaveroussy.fr
Contact: Agnès LAPLANCHE, MD 0142114127 ext +33 agnes.laplanche@gustaveroussy.fr

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Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Lisa LAMBERT    0142116643 ext +33    lisa.lambert@gustaveroussy.fr   
Principal Investigator: Eric BAUDIN, MD, PhD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Advanced Accelerator Applications
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Principal Investigator: Eric BAUDIN, MD Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02230176    
Other Study ID Numbers: 2013-004032-30
2013/2043 ( Other Identifier: CSET number )
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Carcinoma, Islet Cell
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Lutetium Lu 177 dotatate
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action