Neuroendocrine TumorsPhase 2NCT02859064
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
A Phase 2 study testing Lanreotide and Y-90 microspheres in people with Neuroendocrine Tumors and Gastrointestinal Neoplasms, run by SCRI Development Innovations, LLC at 3 sites in United States.
Trial summary
Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Gastrointestinal Neoplasms, Carcinoid Tumors
- What is being tested?
- Lanreotide and Y-90 microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jul 2017to 10 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid or pancreatic islet cell carcinoma.
- Computerized tomography (CT) scan evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. If a CT scan is not possible, then an MRI may be used.
- Patients who are currently receiving or have previously received lanreotide or another somatostatin analogue are eligible. Previous treatment with lanreotide or another somatostatin analogue is not required for study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Adequate hematologic, hepatic and renal function.
- Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months (90 days) following last dose of study drug(s). Male patients must also refrain from donating sperm during their participation in the study and for 3 months after last dose of study drug(s).
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- Life expectancy ≥ 3 months.
- Willingness and ability to comply with study and follow-up procedures.
- Ability to understand the nature of this study and give written informed consent.
Who cannot join
- Anti-cancer therapy with the exception of lanreotide or another somatostatin analogue within 21 days or 5 half-lives (whichever is shorter) of starting study treatment.
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to Cycle 1 Day 1 or has not recovered from side effects of such therapy.
- Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
- Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
- Clinically significant ascites, cirrhosis, portal hypertension, or thrombosis as determined by clinical or radiologic assessment.
- Pregnant or lactating.
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- Acute or chronic liver, renal, or pancreas disease.
- Any of the following cardiac diseases currently or within the last 6 months:
- Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
- QTc interval >480 ms on screening electrocardiogram (ECG)
- Unstable angina pectoris
- Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2
- Acute myocardial infarction
- Conduction abnormality not controlled with pacemaker or medication
- Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
- Valvular disease with significant compromise in cardiac function
- Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] greater than 180 mmHg or diastolic blood pressure (DBP) greater than100 mmHg) (patients with values above these levels must have their blood pressure (BP) controlled with medication prior to starting treatment).
- Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin is allowed.
- Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Known diagnosis of human immunodeficiency virus, hepatitis B or hepatitis C. Lab test results will be confirmed by the treating physician prior to study enrollment using patient's records not more than 1 year old.
- Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Research Medical Center/HCA Midwest
Kansas City, Missouri, 64132
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
About this study
Official title: A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®)
Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.
Read the detailed description
This is an open-label, prospective, multi-center Phase II study for patients with metastatic well-to-moderately differentiated neuroendocrine tumors, including typical carcinoid and pancreatic neuroendocrine tumors, who are candidates for liver-directed radioembolization.
Lanreotide (Somatuline® Depot) Injection, is FDA-approved for treating unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroentero-pancreatic neuro-endocrine tumors (GEP-NETs) to improve progression-free survival. Radioembolization with yttrium-90 microspheres (SIR-Spheres® therapy) is FDA-approved for treating liver metastases from colorectal cancer. While each of these individual treatments has had promising results, investigators hypothesize that treatment for patients with NETs can be optimized by co-administration of both therapies. Patients will receive treatment with lanreotide (120 mg subcutaneously every 28 days) in combination with SIR-Spheres therapy. The dose and treatment day of SIR-Spheres will be determined by the treating radiation oncologist. Patients who are currently receiving or have previously received lanreotide are eligible, and treatment with lanreotide can continue monthly until disease progression or unacceptable toxicity. Up to 25 patients are planned for enrollment to be conducted at approximately 5 investigational sites in the U.S.
- Being tested
- Lanreotide, Y-90 microspheres
- Keywords
- radioembolization, somatostatin analogs, carcinoid, neuroendocrine, liver-directed therapy
- Medical subject headings
- Neuroendocrine Tumors, Gastrointestinal Neoplasms, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanreotideDrug
Also called Somatuline® Depot Injection
Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheresDevice
Also called SIR-Spheres
To be administered by injection through a trans-femoral catheter into the hepatic artery.
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide/Y-90 microspheres | Experimental | Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres [SIR-Spheres therapy]: dose and treatment day to be determined by treating radiation oncologist. Receives: Drug: Lanreotide; Device: Y-90 microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Measured: From the day of the first dose to 30 days after the last dose of study medication, up to 52 months
Secondary outcomes (4)
Overall Response Rate
Percentage of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Measured: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Disease Control Rate
Percentage of patients with CR, PR or stable disease (SD) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): >=30% decrease in the sum of the diameters of target lesions; Stable Disease: Meeting neither criteria for PR or Progression (PD= greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions). Disease Control Rate (DCR) = CR + PR + SD.
Measured: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months.
Progression Free Survival
The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Per RECIST V1.1 criteria, progression is defined as a greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.
Measured: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Overall Survival
The time from Day 1 of study drug administration until death from any cause.
Measured: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start28 Jul 2017
- Primary completion27 May 2022
- Study completion10 Jun 2022
Why it stopped: Closed due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- David Spigel, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859064
- Sponsor's protocol ID
- SCRI GI 221
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2016
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®)
- ClinicalTrials.gov ID
- NCT02859064
- Acronym / sponsor ID
- SCRI GI 221
- Keywords
- radioembolization, somatostatin analogs, carcinoid, neuroendocrine, liver-directed therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.
Detailed description
This is an open-label, prospective, multi-center Phase II study for patients with metastatic well-to-moderately differentiated neuroendocrine tumors, including typical carcinoid and pancreatic neuroendocrine tumors, who are candidates for liver-directed radioembolization.
Lanreotide (Somatuline® Depot) Injection, is FDA-approved for treating unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroentero-pancreatic neuro-endocrine tumors (GEP-NETs) to improve progression-free survival. Radioembolization with yttrium-90 microspheres (SIR-Spheres® therapy) is FDA-approved for treating liver metastases from colorectal cancer. While each of these individual treatments has had promising results, investigators hypothesize that treatment for patients with NETs can be optimized by co-administration of both therapies. Patients will receive treatment with lanreotide (120 mg subcutaneously every 28 days) in combination with SIR-Spheres therapy. The dose and treatment day of SIR-Spheres will be determined by the treating radiation oncologist. Patients who are currently receiving or have previously received lanreotide are eligible, and treatment with lanreotide can continue monthly until disease progression or unacceptable toxicity. Up to 25 patients are planned for enrollment to be conducted at approximately 5 investigational sites in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanreotide/Y-90 microspheres | Experimental | Drug: Lanreotide, Device: Y-90 microspheresLanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy. Y-90 (Yttrium-90) microspheres [SIR-Spheres therapy]: dose and treatment day to be determined by treating radiation oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid or pancreatic islet cell carcinoma.
- Computerized tomography (CT) scan evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. If a CT scan is not possible, then an MRI may be used.
- Patients who are currently receiving or have previously received lanreotide or another somatostatin analogue are eligible. Previous treatment with lanreotide or another somatostatin analogue is not required for study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Adequate hematologic, hepatic and renal function.
Key exclusion criteria (22 listed)
- Anti-cancer therapy with the exception of lanreotide or another somatostatin analogue within 21 days or 5 half-lives (whichever is shorter) of starting study treatment.
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to Cycle 1 Day 1 or has not recovered from side effects of such therapy.
- Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
- Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
- Clinically significant ascites, cirrhosis, portal hypertension, or thrombosis as determined by clinical or radiologic assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LanreotideAlso: Somatuline® Depot InjectionAdministered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs. | Drug | Lanreotide/Y-90 microspheres |
| Y-90 microspheresAlso: SIR-SpheresTo be administered by injection through a trans-femoral catheter into the hepatic artery. | Device | Lanreotide/Y-90 microspheres |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Time frame: From the day of the first dose to 30 days after the last dose of study medication, up to 52 months
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4 secondary outcomes
Overall Response Rate
Time frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Disease Control Rate
Time frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months.
Progression Free Survival
Time frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Overall Survival
Time frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spigel, M.D. study chair
SCRI Development Innovations, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanreotide and Y-90 microspheres in people with Neuroendocrine Tumors and Gastrointestinal Neoplasms, run by SCRI Development Innovations, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability (time frame: From the day of the first dose to 30 days after the last dose of study medication, up to 52 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.