Clinical Trial: Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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 mont
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 18 months ]

RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.


Original Primary Outcome: Response rate (complete and partial response)

Current Secondary Outcome:

  • Plasma Trough Level of GW786034 [ Time Frame: Baseline and day 28 ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline to 18 months. ]
    PFS is defined as the duration of time from start of treatment to time of progression or death.
  • Change in Tumor Blood Flow Assessed by Functional CT [ Time Frame: Baseline and week 12 ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 27, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 15, 2015
Last Verified: May 2015