NCT00427973

AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer

A Phase II Study of AZD2171 in Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer. AZD2171 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. Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171. SECONDARY OBJECTIVES: I. Determine the toxicity of this drug in these patients. II. Determine, preliminarily, the efficacy of this drug, in terms of response rate, duration of response, and overall survival, in these patients. III. Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug. IV. Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dynamic contrast-enhanced (DCE) MRI and CT perfusion scan of the liver are performed at baseline, 72 hours after the initial dose of AZD2171, and at the end of course 1. Blood samples for pharmacokinetic studies are collected periodically during study. After the completion of study treatment, patients are followed every 3 months for 1 year.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Interventions

Type	Name	Description
DRUG	cediranib maleate	Given orally
OTHER	laboratory biomarker analysis	Peripheral blood was obtained from all patients enrolled for studies of early changes in circulating proangiogenic and proinflammatory molecules and cells. Blood samples were collected in EDTA-containing tubes before and after cediranib therapy on days 1 and 14 of cycle 1. Circulating VEGF, placental growth factor (PlGF), sVEGFR1, basic fibroblast growth factor (bFGF), interleukin (IL)-6, IL-8, transforming growth factor a ((TNF-a), gamma interferon (IFN-g) were measured using multiplex ELISA plates from Meso-Scale Discovery. Hepatocyte growth factor (HGF), insulin-like growth factor 1 (IGF-1), sVEGFR2, angiopoietin 2 (Ang-2), sTie2, soluble c-KIT, carbon anhydrase 9 (CAIX), and stromal cell-derived factor-1a (SDF1a) were measured using ELISA kits from R\&D Systems.
PROCEDURE	computed tomography	computed tomography (CT) every 8 weeks to evaluate response and progression.
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Magnetic resonance imaging (MRI) every 8 weeks to evaluate response and progression.
OTHER	pharmacological study	Blood samples to characterize the steady-state PK of cediranib were drawn from a peripheral vein shortly before patients received the dose on days 8 and 15 of cycle 1 and at the following times relative to dosing on day 1 of cycle 2: 5 min and 1, 2, 4, 6, 8, and 24 hours, with the last sample collected before taking the next daily dose.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-04-01
• Completion: 2012-03-01
• First posted: 2007-01-29
• Last updated: 2016-10-31
• Results posted: 2016-10-31

Locations

1 site across 1 country: United States