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Brief Title: Rotating Pazopanib and Everolimus to Avoid Resistance
Official Title: A Randomized Phase II Study to Explore the Efficacy and Feasibility of Upfront Bi-monthly Rotations Between Everolimus and Pazopanib in Patients With Advanced or Metastatic Clear Cell Renal Cancer
Study ID: NCT01408004
Brief Summary: In this study will be examined whether alternating treatment between two classes of drugs (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal cancer.
Detailed Description: Current practice is to treat with VEGFR-TKI or mTOR inhibitors until progression and then continue with the next active agent. From a biological perspective, TKI's will most likely activate compensatory pathways which, may ultimately lead to the development of resistance. Recent studies suggest that resistance to treatment with TKI may be reversible after stopping treatment. There is therefore a rationale to alternate treatment to prevent or delay the occurrence of resistance. Our hypothesis is that alternating active agents in clear cell renal carcinoma (ccRCC) may reduce side effects, improve tolerability and compliance of treatment and prolong progression free survival and overall survival compared to the standard of care.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St. Franciscus Gasthuis, Rotterdam, Zuid-Holland, Netherlands
Medisch Centrum Alkmaar, Alkmaar, , Netherlands
Acedemisch Medisch Centrum Amsterdam, Amsterdam, , Netherlands
NKI-AVL, Amsterdam, , Netherlands
Amphia ziekenhuis Breda, Breda, , Netherlands
Haga Ziekenhuis, Den Haag, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
UMC Groningen, Groningen, , Netherlands
Atrium Medisch Centrum Heerlen, Heerlen, , Netherlands
Medische Centrum Leeuwarden, Leeuwarden, , Netherlands
Acedemisch ziekenhuis Maastricht, Maastricht, , Netherlands
St. Antonius ziekenhuis, Nieuwegein, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Orbis Medisch Centrum, Sittard-Geleen, , Netherlands
St. Elisabeth ziekenhuis, Tilburg, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Isala klinieken, Zwolle, , Netherlands
Name: E.E. Voest, MD/PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR