Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease (VHLSUT)
VHL patients may benefit from sunitinib. This study will investigate the following objectives :
- To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.
- To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
- To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
- To evaluate quality of life in VHL patients receiving sunitinib.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease|
- Objective response rate (RECIST criteria) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]Course: 4 weeks sunitinib / 2weeks rest. Response assessment: after 4 weeks and 8 weeks of sunitinib (1 extra assessment by contrast-enhanced US after 2 weeks for kidney tumors). Then every 6 weeks for eye and every 12 weeks for all other tumors.
- Safety and tolerability (NCI-CTC criteria Version 3.0). [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
- Time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- Quality of life in VHL patients receiving sunitinib. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Treatment with sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).
Treatment until disease progression or unacceptable toxicity.
Dose reduction depending on type and severity of toxicity. At the end of treatment period (after 8 courses), responding and well tolerating patients will be allowed to receive sunitinib upon investigator's opinion.
Follow-up for up to 24 months from inclusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168440
|Hospital Saint André - Service de cancérologie|
|Bordeaux, France, 33075|
|Kremlin-Bicêtre, France, 94275|
|Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale|
|Paris, France, 75015|
|Principal Investigator:||Stephane RICHARD, MD, PhD||Hôpital Kremlin-Bicêtre (France)|
|Study Director:||Reza T ELAIDI, PhD||ARTIC (Hopital Européen Georges Pompidou, FRANCE)|