Bladder Cancer Clinical Trial
Official title:
A Phase I/II Single-Arm Trial to Evaluate the Combination of Cisplatin and Gemcitabine With the mTOR Inhibitor Temsirolimus for First-Line Treatment of Patients With Advanced Transitional Cell Carcinoma of the Urothelium
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin
together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus
given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating
patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.
OBJECTIVES:
Primary
- To determine a safety profile of temsirolimus in combination with cisplatin and
gemcitabine hydrochloride, including dose-limiting toxicities (DLTs) and
maximum-tolerated dose (MTD) in patients with locally advanced and/or metastatic
transitional cell carcinoma of the urothelium. (phase I)
- To determine the recommended dose for the Phase II stage of the trial and subsequent
studies. (phase I)
- To assess progression-free survival (PFS) at six months from date of enrollment. (phase
II)
Secondary
- To determine the pharmacokinetic profile of temsirolimus in combination with cisplatin
and gemcitabine hydrochloride. (phase I)
- To determine tolerability (side-effects) and feasibility (number of participants
requiring dose delays or reduction and/or treatment withdrawal). (phase II)
- To determine objective response rate as assessed by RECIST. (phase II)
- To assess PFS of these patients. (phase II)
- To assess overall survival of these patients. (phase II)
- To determine toxicity during and after treatment in these patients. (phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of temsirolimus followed by a
phase II study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, cisplatin IV
over 3-4 hours on day 1, and temsirolimus IV over 30 minutes on days 1 or 2, 8 or 9, and 15.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
Blood specimens may be collected periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 6 months and 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
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