Ongoing Clinical Trials for Carcinoid Tumours of the Gastrointestinal Tract
Currently, there is 1 ongoing clinical trial investigating treatment options for carcinoid tumours of the gastrointestinal tract. This trial is testing a combination of Lanreotide and Metformin to evaluate its safety in patients with advanced disease. The trial is being conducted in Italy and is open to adults with well-differentiated gastrointestinal or lung carcinoids.
Clinical trial locations
Study on the Safety of Lanreotide and Metformin for Patients with Advanced Gastrointestinal or Lung Carcinoids
This clinical trial is investigating the safety of combining two medications, Lanreotide and Metformin, for patients with advanced carcinoid tumours. These rare tumours can develop in the digestive system or lungs and grow slowly over time. The study is designed as a pilot trial, meaning it is an early-stage investigation to gather preliminary information about how safe this treatment combination is.
Main inclusion criteria:
- Adults over 18 years of age, both male and female
- Confirmed diagnosis of advanced well-differentiated (G1 and G2) gastrointestinal or lung carcinoids that cannot be surgically removed
- Disease progression documented within 6 months before joining the study
- Adequate blood counts: neutrophils greater than 1.5 × 10³/L, platelets greater than 100 × 10³/L, hemoglobin greater than 9 g/dL
- Good kidney function with creatinine clearance equal to or greater than 60 mL/min
- Liver function tests showing bilirubin less than 1.5 times the upper normal limit, and liver enzymes (AST, ALT, alkaline phosphatase) less than 2.5 times the upper normal limit
- ECOG performance status of 2 or less, indicating the patient can care for themselves with some limitations
- Life expectancy of more than 12 months
- Tumor tissue available for analysis
- Female participants of childbearing potential must use effective contraception during the study and for 60 days after
- Male participants with female partners of childbearing potential must also use contraception
Main exclusion criteria:
The trial excludes patients with advanced progressive gastrointestinal or lung carcinoids. While this may seem contradictory given the trial’s focus, this likely refers to specific disease characteristics that would make participation unsafe or interfere with the study results.
Focus and goal:
The primary goal of this study is to evaluate the safety of using Lanreotide in combination with Metformin. Participants will undergo an initial assessment including medical history review, blood tests, and physical examination. Treatment involves Lanreotide given as an intramuscular injection at 120 mg and Metformin taken orally as 850 mg tablets. Throughout the study, participants will be closely monitored with regular check-ups, laboratory tests, and heart assessments to watch for any side effects. The study also measures how long it takes for the disease to progress and evaluates any changes in symptoms. This is an open-label study, meaning both participants and researchers know which treatments are being given.
Investigational drugs:
Lanreotide is a medication that mimics a natural hormone in the body to help control tumor growth by reducing the release of growth factors and other hormones. It belongs to a class of drugs called somatostatin analogues and is administered as an injection.
Metformin is commonly used to manage blood sugar levels in people with type 2 diabetes. In this trial, researchers are exploring whether it can provide additional benefits when combined with Lanreotide for treating carcinoid tumours. Metformin may affect tumour growth and metabolism, which is why it is being studied in this context.
Summary
Currently, there is only one clinical trial specifically focused on carcinoid tumours of the gastrointestinal tract, located in Italy. This pilot study is investigating the safety of combining Lanreotide, a hormone-like medication used to control tumour growth, with Metformin, a drug typically used for diabetes management. The trial is open to adults with advanced disease that cannot be surgically removed and requires participants to have adequate organ function and a reasonable life expectancy. This small-scale study represents an important step in exploring new treatment combinations for these rare tumours.