Clinical Trials Logo

Clinical Trial Summary

This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.

OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints.

Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00131911
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date June 2005
Completion date April 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Completed NCT00789841 - Gastrointestinal Motility in Patients With Neuroendocrine Tumors N/A
Recruiting NCT05069220 - 18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor Early Phase 1
Completed NCT05816720 - Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT01849523 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study N/A
Recruiting NCT01448083 - Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours N/A
Completed NCT00804336 - Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors Phase 1
Active, not recruiting NCT02092714 - Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors
Terminated NCT04073017 - Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency N/A
Completed NCT00434109 - Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization Phase 2
Completed NCT02472678 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor N/A
Completed NCT02481804 - Optimal Feeding for NET Patients N/A
Completed NCT02147106 - Use of Video Consultation in Follow-up Care for Patients With a Neuroendocrine Tumor: a Feasibility Study
Completed NCT00165230 - Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors Phase 2
Active, not recruiting NCT03012789 - Surgical Intervention and the NETest N/A
Not yet recruiting NCT02038738 - 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors Phase 1/Phase 2
Completed NCT01024387 - AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Phase 2
Terminated NCT00227617 - Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors Phase 2/Phase 3