Hormone Refractory Prostate Cancer Clinical Trial
Official title:
Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated With Docetaxel
This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel
for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with
Docetaxel.
The purpose of this study is to evaluate the activity of the weekly administration of
cabazitaxel as time to progression by PSA at week 12.
The efficacy of three-weekly cabazitaxel is accompanied by an appreciable rate of serious
side effects and toxic deaths. The toxicity rates observed, including grade III-IV
neutropenia, febrile neutropenia and diarrhea, could be an obstacle to the use and management
of a drug that, on the other hand, has demonstrated great activity. In the treatment of
patients with prostate cancer, who have a larger number of morbidities than patients with
breast cancer, we assume the risk that in the transition from clinical trial to clinical
practice the drug will not be used much because of the risk of side effects, cost, the
discomfort derived from the routine use of G-CSF and the lack of patient compliance with this
type of regimens.
Rates of neuropathy, nail and conjunctive toxicity with this new taxane are not relevant,
which suggests that weekly administration will not produce relevant toxicity problems. Weekly
administration of other taxanes improved hematologic tolerance along with a better
therapeutic range in some cases, increasing the dose intensity and activity without
increasing the associated toxicity.
Phase I study has been reported studying weekly administration of cabazitaxel, recommended
dose is 10 mg/m2, administered on days 1, 8, 15 and 22 every 5 weeks in a 1-hour infusion,
being diarrhea the dose-limiting toxicity observed in this study.
Given the pharmacokinetic characteristics of this taxane and its activity and toxicity
profile, cabazitaxel might be a good candidate for studying in a weekly administration
regimen in patients with prostate cancer with a greater risk of toxicity associated with
treatment every 3 weeks, such as patients who have received previous pelvic radiation therapy
that affects more than 25% of the bone marrow reserve, patients over 75 years with a worse
performance status (ECOG 2) or who have already experienced important hematologic toxicity in
the previous treatment with docetaxel.
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