Clinical Trial: Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease
Brief Summary:
VHL patients may benefit from sunitinib. This study will investigate the following objectives :
PRIMARY OBJECTIVE
- 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.
SECONDARY OBJECTIVES
- 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.
Detailed Summary:
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.
Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Current Primary Outcome: Objective response rate (RECIST criteria) [ Time Frame: Every 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability (NCI-CTC criteria Version 3.0). [ Time Frame: Every 6 weeks ]
- 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 ]
- Quality of life in VHL patients receiving sunitinib. [ Time Frame: Every 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Dates:
Date Received: March 18, 2010
Date Started: March 2010
Date Completion:
Last Updated: September 12, 2012
Last Verified: September 2012