Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Carcinoid Tumor
Carcinoma
Carcinoma, Islet Cell
Carcinoma, Neuroendocrine
Endocrine Gland Neoplasms
Gastrin-Producing Neuroendocrine Tumor
Gastrinoma
Gastrointestinal Neoplasms
Glucagonoma
Insulinoma
Intestinal Neoplasms
Lung Carcinoid Tumor
Malignant Carcinoid Syndrome
Metastatic Digestive System Neuroendocrine Tumor G1
Multiple Endocrine Neoplasia
Multiple Endocrine Neoplasia Type 1
Neuroendocrine Tumors
Pancreatic Glucagonoma
Pancreatic Insulinoma
Pancreatic Neoplasms
Pancreatic Polypeptide Tumor
Recurrent Digestive System Neuroendocrine Tumor G1
Recurrent Pancreatic Neuroendocrine Carcinoma
Regional Digestive System Neuroendocrine Tumor G1
Somatostatin-Producing Neuroendocrine Tumor
Somatostatinoma
Stomach Neoplasms

Clinical Trial Details

NCT number	NCT00454363
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	March 2007
Completion date	December 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms