NCT00454363

Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer

A Phase 2 Study of GW786034 (Pazopanib) in Advanced Low-Grade or Intermediate-Grade Neuroendocrine Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced neuroendocrine cancer. Pazopanib hydrochloride 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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) (complete and partial response) of GW786034 (pazopanib hydrochloride) 800 mg administered orally once daily in patients with advanced low or intermediate grade carcinoid tumors (in carcinoid cohort). II. To determine the objective response rate (ORR) (complete response and partial response) of GW786034 800mg administered orally once daily in patients with advanced low or intermediate grade pancreatic islet cell carcinoma (in islet cell cohort). SECONDARY OBJECTIVES: I. To determine the progression free survival (PFS) duration of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma. II. To determine the safety and tolerability of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma. III. To explore the effect on tumor blood flow as determined by functional computed tomography (CT) of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma. IV. To assess the trough level of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma. OUTLINE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 90 days for up to 18 months.

Conditions

• Gastrin-Producing Neuroendocrine Tumor
• Lung Carcinoid Tumor
• Metastatic Digestive System Neuroendocrine Tumor G1
• Multiple Endocrine Neoplasia Type 1
• Pancreatic Glucagonoma
• Pancreatic Insulinoma
• Pancreatic Polypeptide Tumor
• Recurrent Digestive System Neuroendocrine Tumor G1
• Recurrent Pancreatic Neuroendocrine Carcinoma
• Regional Digestive System Neuroendocrine Tumor G1
• Somatostatin-Producing Neuroendocrine Tumor

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pazopanib Hydrochloride	Given PO
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2007-03-01
• Primary completion: 2014-03-01
• Completion: 2014-12-01
• First posted: 2007-03-30
• Last updated: 2020-04-03
• Results posted: 2015-04-01

Locations

3 sites across 1 country: United States