Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 18 months]. Number, participants. PR: Pazopanib + Carcinoid (n=20): 0; Pazopanib + pNET (n=31): 6. SD: Pazopanib + Carcinoid (n=20): 14; Pazopanib + pNET (n=31): 21. PD: Pazopanib + Carcinoid (n=20): 3; Pazopanib + pNET (n=31): 3. Not Evaluable: Pazopanib + Carcinoid (n=20): 3; Pazopanib + pNET (n=31): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percent Change in Tumor Blood Flow Assessed by Functional CT [Baseline and week 12]. Median, percentage of change in tumor blood flow (Full Range). Pazopanib + pNET (n=11): 139 (-56 to 154).