Study on the Effectiveness and Safety of Lutathera for Patients with Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
Sponsor: Advanced Accelerator Applications
ClinicalTrials ID:NCT03972488
This clinical trial is testing whether the drug Lutathera, combined with octreotide, can help patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) live longer without their cancer getting worse. The study compares this combination to a higher dose of octreotide alone.
Patient Parameters
| Parameter | Options |
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Program Overview
The NETTER-2 study aims to find out if using Lutathera with octreotide can extend the time patients with high-grade gastroenteropancreatic neuroendocrine tumors (GEP-NET) live without their cancer progressing. This treatment is being tested as a first option compared to a higher dose of octreotide alone. Patients who have not used somatostatin analogs before, as well as those who have used them without their cancer worsening, can participate.
Description
The study includes several phases: a screening phase to determine eligibility, a treatment phase where patients receive either Lutathera with octreotide or a higher dose of octreotide alone, and optional phases for patients to switch treatments or receive additional Lutathera if needed. Lutathera is given in four doses every eight weeks, along with octreotide. The study compares this to a higher dose of octreotide given every four weeks.
Eligibility Criteria
Inclusion Criteria
- Have advanced, inoperable gastroenteropancreatic neuroendocrine tumors (GEP-NET) diagnosed within the last six months.
- Tumors must have a specific growth rate (Ki67 index between 10% and 55%).
- Be 15 years or older and weigh more than 40 kg.
- Tumors must show somatostatin receptors on scans done within three months before starting the study.
- Tumor uptake on scans must be higher than normal liver uptake.
- Have a Karnofsky Performance Score of 60 or higher, indicating the ability to care for oneself with some assistance.
- Have at least one measurable tumor site.
- Must provide signed consent to participate in the study.
Exclusion Criteria
- Poor kidney function (creatinine clearance less than 40 mL/min).
- Low blood counts or abnormal liver function tests.
- Pregnant or breastfeeding women.
- Women who can become pregnant must use effective birth control during the study and for seven months after.
- Previous treatment with peptide receptor radionuclide therapy (PRRT).
- Cancer progression after previous treatments for GEP-NET.
- Other treatments considered more suitable by the doctor.
- Previous treatments with certain cancer drugs or therapies within 12 weeks before the study.
- Recent surgery or treatments for GEP-NET.
- Untreated or unstable brain metastases.
- Severe heart failure or heart rhythm issues.
- Uncontrolled diabetes or high potassium levels.
- Inability to stop certain medications before Lutathera treatment.
- Other serious medical conditions that could interfere with the study.
- Previous extensive radiation therapy to the bone marrow.
- Current urinary incontinence.
- Other cancers unless treated and stable for five years.
- Allergies to study drugs or imaging agents.
- Participation in another clinical study within the last 30 days.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale Cancer Center | 06520 | New Haven | Connecticut |
| USF - H. Lee Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| University of Iowa Hospitals and Clinics - Oncology | 52242 | Iowa City | Iowa |
| University of Kentucky UK Markey Cancer Center | 40536 | Lexington | Kentucky |
| Mayo Clinic - Oncology | 55905 | Rochester | Minnesota |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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