Clinical Trials Logo
  1. Home
  2. Insulinoma
  3. NCT01824875

Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

Insulinoma Clinical Trial

Official title:
A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors

Clinical Trial Summary

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. SECONDARY OBJECTIVES: I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine. V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01824875
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 8, 2013
Completion date December 2024
View Details
See also
  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
Completed NCT00075439 - Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors Phase 2
Terminated NCT04452396 - CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia N/A
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1