Insulinoma Clinical Trial
Official title:
A Phase II Trial of ZD1839 (Iressa®) in Metastatic Neuroendocrine Tumors
This phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES:
I. To determine the 6 month progression free survival rate in patients with progressive,
advanced neuroendocrine tumors treated with ZD1839.
SECONDARY OBJECTIVES:
I. Objective tumor response rate. II. Progression free survival and time to progression.
III. Improvement in circulating hormone levels. IV. Overall survival V. We will explore the
molecular characterization of these tumors in attempt to understand the role of EGFR
expression and its inhibition with ZD1839 in neuroendocrine tumors. The measurements will be
performed on pretreatment and post-treatment tumor biopsies when possible: EGFR expression
and gene amplification (IHC for EGFR and phosphorylated EGFR, ISH for gene amplification);
Activation of the Ras/Raf/MAPK pathway (IHC for phosphorylated MAPK); Cell proliferation
(Ki-67 staining); Apoptosis (TUNEL assay).
OUTLINE: This is a multicenter study. Patients are stratified according to disease type
(carcinoid vs islet cell and other neuroendocrine tumors).
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for
up to 2 years from study entry.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02021604 -
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
|
Phase 1 | |
| Withdrawn |
NCT02108782 -
Dovitinib Lactate in Treating Patients With Pancreatic Neuroendocrine Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT05034783 -
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients
|
Early Phase 1 | |
| Terminated |
NCT02273752 -
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00937079 -
Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients
|
Phase 1 | |
| Recruiting |
NCT04185350 -
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
|
Early Phase 1 | |
| Recruiting |
NCT00001276 -
Diagnosing and Treating Low Blood Sugar Levels
|
||
| Active, not recruiting |
NCT02121366 -
EUS-guided Ethanol Ablation of an Insulinoma
|
N/A | |
| Terminated |
NCT00084461 -
Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00131911 -
Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00005910 -
Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
|
N/A | |
| Recruiting |
NCT03583528 -
DOTATOC PET/CT for Imaging NET Patients
|
||
| Withdrawn |
NCT04915144 -
177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs
|
Phase 2 | |
| Recruiting |
NCT05523778 -
A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct
|
N/A | |
| Recruiting |
NCT02560376 -
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
|
Phase 0 | |
| Completed |
NCT01525082 -
Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00655655 -
Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04452396 -
CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia
|
N/A | |
| Active, not recruiting |
NCT01824875 -
Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00004074 -
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
|
Phase 1 |