Trial Information

Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder

OBJECTIVES:

Primary

- Determine the incidence and nature of acute and late toxicity of gemcitabine
hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III
transitional cell carcinoma of the bladder. (Phase I)

- Determine the efficacy of this regimen, in terms of local tumor control (absence of
local progression), in these patients. (Phase II)

Secondary

- Determine the maximum tolerated dose and the recommended phase II dose of gemcitabine
hydrochloride when administered with cisplatin and radiotherapy in these patients.
(Phase I)

- Assess the 5- and 10-year survival and the progression-free survival of patients
treated with this regimen. (Phase II)

- Assess the quality of life of patients treated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a
phase II, multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes twice weekly for 5 weeks and
cisplatin IV continuously over 4 days on days 2-5 and 23-26 (weeks 1 and 4). Patients also
undergo radiotherapy once daily 5 days a week for 5 weeks.

Three weeks after completion of treatment, patients undergo cystoscopy and transurethral
resection (TUR). Patients with residual tumor or disease progression undergo radical TUR.
After surgery, patients who achieve a complete response receive gemcitabine hydrochloride IV
twice weekly for 2 weeks and cisplatin IV continuously over 4 days in week 1. Patients also
undergo radiotherapy once daily 5 days a week for 2 weeks.

After completion of study treatment, patients are followed at 6-8 weeks and then 6 months
thereafter.