Clinical Trials /

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

NCT04609592

Description:

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

Related Conditions:
  • Gastrointestinal Neuroendocrine Tumors
  • Pancreatic Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04609592

Trial Eligibility

Document

Title

  • Brief Title: Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
  • Official Title: Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery

Clinical Trial IDs

  • ORG STUDY ID: IRB- 52341
  • SECONDARY ID: NET0030
  • NCT ID: NCT04609592

Conditions

  • Gastroenteropancreatic Neuroendocrine Tumor

Interventions

DrugSynonymsArms
Lutatheralutetium Lu 177 dotatate, (Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10- tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic (2-7) disulfide., 177 Lu-DOTA-octreotateLutathera
Gallium 68 DotatateGallium-68 DOTA-DPhe1, Tyr3-octreotateLutathera

Purpose

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

Detailed Description

      Primary Objective(s)

        -  To assess feasibility and safety of combination of perioperative 177Lu Dotatate and
           cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)

        -  To assess response rate (RR) after 2 cycles 177Lu Dotatate

        -  To assess recurrence free survival (RFS) of the overall treatment strategy

        -  To assess overall survival (OS) of the overall treatment strategy

Trial Arms

NameTypeDescriptionInterventions
LutatheraExperimental2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
  • Lutathera
  • Gallium 68 Dotatate

Eligibility Criteria

        Inclusion Criteria:

          1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.

          2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)

          3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as
             determined by a multidisciplinary tumor board discussion

          4. Measurable disease as determined by RECIST v1.1

          5. Confirmed presence of somatostatin receptors on all target lesions as determined by
             68Ga DOTA TATE PET scan

          6. Patients ≥ 18 years of age.

          7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

          8. Appropriate hematologic, liver and kidney function

          9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at
             3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study

        Exclusion Criteria:

          1. Prior 177Lu Dotatate treatment

          2. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the
             study; or prior radioembolization; chemoembolization; or external beam radiation
             therapy (EBRT) to > 25% of bone marrow, at any time

          3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4
             weeks prior to enrollment in the study

          4. Known brain metastases

          5. Known bone or peritoneal metastases
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Measure Complication free Surgery
Time Frame:6 months
Safety Issue:
Description:The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. Radiation fibrosis Hepatic fibrosis by histologic diagnosis Hepatic insufficiency Bowel anastamotic leak (if bowel surgery) Distal pancreatic leak (if pancreas surgery)

Secondary Outcome Measures

Measure:Response Rate (RR)
Time Frame:16 weeks
Safety Issue:
Description:Response Rate (RR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, will be determined after 2 pre operative cycles of 177Lu Dotatate. RR will be assessed as the sum of complete response (CR) and partial response (PR), and expressed as a number without dispersion. RECIST criteria are: CR = Disappearance of all target lesions PR = ≥ 30% decrease in the sum of the longest diameter of target lesions Response Rate (RR) = CR + PR Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria
Measure:Recurrence free Survival (RFS)
Time Frame:1 year
Safety Issue:
Description:Recurrence free Survival (RFS) is defined as the number and proportion of participants that remain alive from the start of treatment without relapse or recurrence of disease, expressed as a number without dispersion.
Measure:Overall Survival (OS)
Time Frame:1 year
Safety Issue:
Description:Overall survival (OS) is defined as the number and proportion of participants that remain alive from the start of treatment, expressed as a number without dispersion.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Stanford University

Last Updated

April 19, 2021