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)

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)
Gastrointestinal Stromal Tumor
Start Date 05/01/2008
Age of Trial (yrs) 14.2
Treatment Phase:
Drug Category:
KIT/PDGFRA inhibitor
Block KIT
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
Radboud University
Patient Contact:
C.M.L. van Herpen, Md, Phd 31 24 3610353 S. Mulders, Md 31 24 3610353
Contact email:
Contact Phone:
IV or 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)
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

6525 GH