Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer (Abraxane)
Recruitment status was: Recruiting
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.
|Bladder Cancer||Drug: Paclitaxel, nanoparticle albumin-bound||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. [ Time Frame: 6 weeks, 4 months, 6 months ]
- To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial TCC as measured by response rate (defined as negative cytology and bladder biopsy). [ Time Frame: 6 weeks, 4 months, 6 months ]
- To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy. [ Time Frame: 6 weeks, 4 months, 6 months ]
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Abraxane administration
Patients will restrict their fluid intakes the morning of treatments and will have emptied their bladders at each of their visits and have up to 100ml of Abraxane solution administered to their bladder via urinary catheter once weekly for six weeks.
Drug: Paclitaxel, nanoparticle albumin-bound
Intravesically administered, dose escalation, 6 weekly instillations
Other Name: Abraxane
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583349
|Contact: Sam Cammackfirstname.lastname@example.org|
|United States, New York|
|Herbert Irving Pavillion 11th Floor||Recruiting|
|New York, New York, United States, 10032|
|Contact: LaMont J Barlow 212-305-6665 email@example.com|
|Principal Investigator: James M McKiernan, MD|
|Principal Investigator:||James M McKiernan, MD||Columbia University Medical Center, Urology|