Trials / Active Not Recruiting

Active Not RecruitingNCT01841736

Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

Prospective Randomized Phase II Trial of Pazopanib (NSC #737754) Versus Placebo in Patients With Progressive Carcinoid Tumors

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 171 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) will be compared between patients randomized to treatment with pazopanib (pazopanib hydrochloride) versus placebo. SECONDARY OBJECTIVES: I. Overall survival (OS) will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms. III. Progression free survival (PFS) as assessed by central radiology review and local radiology review will be compared overall and within treatment arms. IV. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm. V. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo. VI. To determine the turn-around time for timely adjudicated central review. VII. To characterize the nature of discordance between local and central radiology review in assessment of progression. VIII. To characterize the type and rate of progression in carcinoid (at study entry, on-study, and at progression). IX. To develop new methods for modeling carcinoid growth and detecting treatment effects, and to perform simulations that advance new clinical trial designs to apply to future trials of carcinoid therapeutics. X. To assess for differences in quality of life (QOL)-related domains between the two treatment groups (pazopanib versus placebo). XI. To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (European Organization for Research and Treatment of Cancer \[EORTC\], neuroendocrine tumors \[NET\]21). XII. To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms. XIII. To determine whether components of the plasma angiome panel that have been shown to be predictive previously (interleukin-6 \[IL-6\] and vascular endothelial growth factor \[VEGF\]-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202. XIV. To determine whether other components of the plasma angiome panel tested (not IL-6 and VEGF-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202. XV. To evaluate the changes in the plasma angiome markers after treatment with or without pazopanib over time. EXPLORATORY OBJECTIVES: I. PFS at 6 months will be estimated within each treatment arm. II. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid \[5-HIAA\], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study. ARM II: Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study. After completion of study treatment, patients are followed up every 3-6 months for 5 years.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Echocardiography Test	Undergo ECHO
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
DRUG	Pazopanib Hydrochloride	Given PO
OTHER	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	X-Ray Imaging	Undergo chest x-ray

Timeline

Start date: 2013-09-20
Primary completion: 2019-03-05
Completion: 2026-09-10
First posted: 2013-04-26
Last updated: 2026-04-13
Results posted: 2020-06-01

Locations

424 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01841736. Inclusion in this directory is not an endorsement.