TEM Timing

Titre officiel

The Timing of Temsirolimus in Patients with Metastatic Renal Cell Carcinoma

Sommaire:

Cette étude de recherche a pour but de déterminer si le moment de la journée où les patients reçoivent du temsirolimus (Torisel) influe sur l’activité du médicament contre le cancer et de déterminer la fréquence et la gravité des effets secondaires.

Description de l'essai

The primary objective is to study if the timing of Temsirolimus therapy impacts the therapeutic index in RCC patients with regard to: 1) activity as measured by surrogate markers of antiangiogenic activity and mTor inhibition and 2) toxicity as measured by NCIC common toxicity criteria, actigraphy, quality of life scales and inflammatory cytokines.

This is a Randomized phase-II study. Temsirolimus will be administered i.v weekly. Patients will be randomized to start therapy at 9-10 AM vs. 12-1 PM vs. 4-5 PM

Surrogate markers of antiangiogenic activity, mTOR inhibition and markers of quality of life and fatigue will only be studied during the first 12 weeks of Temsirolimus therapy. Detailed toxicity data will be collected for the first two courses. Patients will then continue therapy at the time they were randomized to. During continued therapy data will be collected for dose reductions, treatment delays, number of courses given and response.