Intravesical docetaxel appears safe in TCC patients

An intravesical formulation of the chemotherapy agent docetaxel (Taxotere) appears to be safe for further investigation in patients with superficial bladder cancer that has recurred following standard therapies, according to findings from a phase I trial published in the Journal of Clinical Oncology (2006; 24:3075-80).

The study included 18 patients with recurrent transitional cell carcinoma: six with Tis, seven with Ta, and five with T1 disease. All patients experienced treatment failure with at least one prior intravesical treatment.

Patients received six weekly instillations of docetaxel at a starting dose of 5 mg, with a dose-escalation model until a maximum tolerated dose was achieved.

Nearly half (44%) of patients experienced grade 1 or 2 toxicities, but none of the patients had systemic absorption of docetaxel, reported the authors, led by James M. McKiernan, MD, of the Columbia University Medical Center, New York. About half of the patients did not have evidence of disease at their post-treatment cystoscopy and biopsy, and none of the relapsed patients had disease progression.