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

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04609592
• Other study ID #: IRB-52341
• Secondary ID: NET0030NCI-2021-
• Status: Recruiting
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: September 2027

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Gino Pinedo
• Phone: 650-725-8474
• Email: gpineda[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2027
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumor
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Lutathera
4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T
• Gallium 68 Dotatate
Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)

Procedure:
• Computed Tomography (CT)
Medical Imaging
• Magnetic Resonance Imaging (MRI)
Medical Imaging
• PET/CT
Medical Imaging

Locations

Country	Name	City	State
United States	Stanford Cancer Institute Palo Alto	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Complication free Surgery	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)	6 months
Secondary	Response Rate (RR)	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	16 weeks
Secondary	Recurrence free Survival (RFS)	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.	1 year
Secondary	Overall Survival (OS)	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.	1 year