Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib
This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib.
In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed.
In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.
Non-clear Cell Renal Cell Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma|
- Time to progression [ Time Frame: 7-11 months expected ] [ Designated as safety issue: No ]
- Objective response [ Time Frame: 7-11 months expected ] [ Designated as safety issue: No ]
- safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs [ Time Frame: 8-12 months (treatment duration + 1 months) ] [ Designated as safety issue: Yes ]
- one year progression free survival rate (1YPFSR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- overall survival (OS) [ Time Frame: will be evaluated in 2013 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
25 mg intravenously, once weekly infusion
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
|Vivantes Klinikum am Urban|
|Charité - Campus Virchow Klinikum|
|Charité - Mitte|
|Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus|
|Klinikum der J.W. Goethe Universität|
|UK-SH Campus Lübeck|
|Klinikum Oldenburg gGmbH|
|Klinikum Stuttgart, Katharinenhospital|
|Facharzt für Innere Medizin,|
|Kliniken Nordoberpfalz AG - Klinikum Weiden|