Clinical Trials for Carcinoid Tumour Pulmonary
There is currently 1 ongoing clinical trial for patients with carcinoid tumour pulmonary (also known as: lung carcinoid tumors, pulmonary carcinoid). This trial is investigating the safety of combining Lanreotide and Metformin for patients with advanced gastrointestinal or lung carcinoids, and is being conducted in Italy.
Clinical trial locations
Study on the Safety of Lanreotide and Metformin for Patients with Advanced Gastrointestinal or Lung Carcinoids
This clinical trial is an open-label pilot study investigating the safety of combining two medications for patients with advanced forms of carcinoid tumors affecting either the digestive system or lungs. The study aims to gather preliminary information about how safe it is to use these two drugs together in this patient population.
Main focus and goal: The primary purpose of this study is to evaluate the safety of using Lanreotide in combination with Metformin in patients with advanced well-differentiated gastrointestinal or lung carcinoids. Researchers will monitor participants closely for any side effects or adverse reactions to this treatment combination. The study will also assess how effective the treatment is by measuring the time it takes for the disease to progress and evaluating any improvements in symptoms experienced by patients.
Investigational drugs: The trial uses two medications: Lanreotide, which is given as an intramuscular injection at a dose of 120 mg using a pre-filled syringe, and Metformin, which is taken orally as film-coated tablets at a dosage of 850 mg per tablet. Lanreotide is a type of medication that mimics a natural hormone in the body to help control tumor growth by inhibiting the release of hormones and growth factors. Metformin, commonly used to manage blood sugar levels in people with type 2 diabetes, is being studied in this context for its potential effects on tumor growth and metabolism.
Who can participate (inclusion criteria):
- Adults over 18 years of age, both male and female
- Patients with a confirmed diagnosis of advanced well-differentiated (G1 and G2) gastrointestinal or lung carcinoids, according to the latest WHO Classification criteria
- Disease that cannot be surgically removed, as determined by a specialized medical team
- Measurable disease and confirmed disease progression within 6 months before joining the study
- Life expectancy of more than 12 months
- ECOG performance status of 2 or less, meaning the disease does not severely affect daily activities
- Adequate blood test results showing sufficient counts of neutrophils (white blood cells), platelets, and hemoglobin, as well as proper liver and kidney function
- Tumor tissue available for analysis
- Documented uptake on Octreoscan/PET Ga scan or positive staining for SSTR2 receptor within 6 months before enrollment
- Patients who may have previously received treatment with surgery, chemotherapy, somatostatin analogues, m-TOR inhibitors, or other systemic cancer therapies
- Patients with either functioning or non-functioning tumors
- Patients with type 2 diabetes or normal blood sugar levels
- Female participants of childbearing potential must use reliable birth control methods during the study and for at least 60 days afterward
- Male participants with female partners of childbearing potential must also use reliable birth control during the study and for 60 days afterward
Who cannot participate (exclusion criteria): Patients with advanced progressive gastro-intestinal or lung carcinoids that are worsening rapidly are not eligible for this trial. The specific exclusion criteria are designed to ensure patient safety during the study.
What happens during the trial: Participants will first undergo an initial assessment that includes a review of their medical history, physical examination, and blood tests to confirm eligibility. Once enrolled, treatment begins with regular administration of both Lanreotide injections and Metformin tablets. Throughout the study, participants will receive ongoing monitoring through regular check-ups, physical examinations, laboratory tests, and cardiac assessments to evaluate the safety and effectiveness of the treatment. The study will measure the time it takes for the disease to progress and assess any changes in symptoms. At the end of the study period, a final assessment will be conducted to evaluate overall health status and any long-term effects of the treatment.
Summary
Currently, there is only one clinical trial available for patients with pulmonary carcinoid tumors, located in Italy. This trial is notable for exploring a combination treatment approach using Lanreotide, a medication specifically designed to manage neuroendocrine tumors, together with Metformin, a diabetes medication that may have additional benefits in cancer treatment. The study is particularly inclusive, accepting patients who have previously received other treatments and those with either functioning or non-functioning tumors. This pilot study represents an important step in understanding new treatment options for patients with advanced carcinoid tumors that cannot be surgically removed.