TRIAL DETAIL

Study on the Influence of Sunitinib and Sorafenib on Fatigue, Quality of Life and Depression in Patients With Metastatic Renal Cell Cancer or Gastrointestinal Stromal Tumor (GIST)

Drug:
Trial Name:
Study on the Influence of Sunitinib and Sorafenib on Fatigue, Quality of Life and Depression in Patients With Metastatic Renal Cell Cancer or Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
Start Date 05/01/2008
Age of Trial (yrs) 14.2
Treatment Phase:
Palliative
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
UMCNONCO20082
Sponsor:
Radboud University
Patient Contact:
C.M.L. van Herpen, Md, Phd 31 24 3610353 c.vanherpen@onco.umcn.nl S. Mulders, Md 31 24 3610353 s.mulders@onco.umcn.nl
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
The purpose of this study is to assess the influence of Sunitinib and Sorafenib on fatigue, quality of life and depression in patients with metastatic renal cell or colorectal cancer or GIST. In order to get more insight in the mechanism of vascular endothelial growth factor (VEGF) related fatigue and if possible to come to a resolution for this side effect.

During the study three questionnaires must repeatedly be completed in by the patients: the BDI (PC) a depression scale, the EORTC-QLQ a quality of life assessment and the CIS20r, a fatigue scale and patients must fill in their medication on a list.

Trial Links

Trial Results

Drug Information

All about Sutent (LRG website)
 
Sutent.com
 
Managing the side effects of sunitinib: a practical guide
 
The Molecular Basis of Class Side Effects Due to Treatment with Inhibitors of the VEGF/VEGFR Pathway
 
Evolving Strategies for the Management of Hand–Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib (Full text available)
 
Drug interactions (LRG site)
 
Sutent prescribing information
 
Adverse effects information for Sutent
 
Gleevec/Sutent drug interactions - by Alessandro Pasina
 
Sutent given U.S. approval (LRG story)
 
Sutent + Avastin trial halted - reports of several cases of microangiopathic hemolytic anemia (MAHA).
 
Better monitoring for Sutent-related heart problems may be warranted
 
Cardiotoxicity associated with another smart cancer drug, sunitinib (heartwire article)
 
Stability of sunitinib in oral suspension
 
Managing the side effects of sorafenib and sunitinib (PDF)
 
Sutent Patient Assistance Program in China
 
Marginal increase of sunitinib exposure by grapefruit juice
 
A pediatric phase I trial and pharmacokinetic (PK) study of sunitinib: A Children’s Oncology Group Phase I Consortium study
 
Hypertension (HTN) as a potential biomarker of efficacy in patients (pts) with gastrointestinal stromal tumor (GIST) treated with sunitinib (SU)
 
Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure
 
Phase I and Pharmacokinetic Study of Sunitinib in Pediatric Patients with Refractory Solid Tumors: A Children's Oncology Group Study
 
Sunitinib-induced cardiotoxicity is mediated by off-target inhibition of AMP-activated protein kinase (full-text article)
 
Suppression of the Nitric Oxide Pathway in Metastatic Renal Cell Carcinoma Patients Receiving VEGF inhibitors (PDF)
 
Tolerability and pharmacokinetic profile of a sunitinib powder formulation in pediatric patients with refractory solid tumors: a Children's Oncology Group study
 
Management of side effects associated with sunitinib therapy for patients with renal cell carcinoma (PDF)
 
Transient sunitinib resistance in GIST
 
Prospective Evaluation of Sunitinib-Induced Cardiotoxicity in Patients with Metastatic Renal Cell Carcinoma
 
Population Pharmacokinetics of Sunitinib and it's active Metabolite SU012662 in Pediatric Patients with GIST or Other Solid Tumors
 

Trial Sites

Name
Address
City
State
Zip
Country
Nijmegen
Gelderland
6525 GH
Netherlands