Bladder Cancer Clinical Trial
Official title:
A Combined Phase I & II Trial of Intravesicular Abraxane, a Nanoparticle Albumin-bound Paclitaxel, for Treatment-refractory Transitional Cell Carcinoma of the Urinary Bladder
The intravesical treatment of bladder cancer with Abraxane is more desirable than other
taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it
greater access to sites in the bladder. Thus, we are interested in investigating Abraxane's
safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell
cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is designed
as a dose-escalation study with cohorts of threes that will enroll a maximum of 18 patients.
Dose increases will occur in groups of three patients, with each successive group receiving
an increased concentration of Abraxane intravesically. No dose increase will occur until each
member of the previous cohort has undergone the first instillation of the medication without
experiencing a dose-limiting toxicity (DLT). Any patient who experiences a DLT will be
removed from the trial and treated appropriately.
If one patient in the cohort experiences a DLT an additional three patients will be enrolled
and treated at that dose-level. If none of the additional three patients experience a DLT,
the next group of patients will be started on the next higher dose level.
If at any dose level, two or more patients experience a DLT the previous dose level will be
considered as the maximum tolerated dose (MTD). An additional three patients (for a total of
six patients) will then be treated at the MTD. If less than two patients experience a DLT
this dose level will be established as the MTD. The phase II aspect is designed in a Simon II
stage format in which to satisfy our study powering, the first stage there will be 10
patients enrolled. If there are 2 or more successful treatments in that group (negative urine
cytology and bladder biopsy after 6 months), then the first stage will pass the rejection
rule, and up to another 19 patients will be enrolled. If at any point in the study, there
have been a total of 6 or more successes, then the phase II aspect will be considered a
successful trial and the study will be completed at that point.
n/a
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