Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer
This phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.
PRIMARY OBJECTIVES:
I. To define the maximum-tolerated dose (MTD) of sirolimus (rapamycin) combined with
gemcitabine hydrochloride and cisplatin (GC). (Phase I)
II. To determine the pathologic complete response rate at cystectomy in patients with
localized, muscle invasive carcinoma of the bladder (clinical tumor [T]2-4, node [N]0 or N1).
(Phase II)
SECONDARY OBJECTIVES:
I. To assess the response rate to rapamycin combined with GC. (Phase I)
II. To assess effect of rapamycin with GC on deoxyribonucleic acid (DNA) damage surrogates in
cancer associated stroma compared to untreated and GC treated stroma. (Phase I)
III. To assess effect of rapamycin with GC on DNA damage surrogates in cancer associated
stroma compared to untreated and GC treated stroma. (Phase II)
IV. To assess toxicity of the MTD dose of rapamycin with GC. (Phase II)
OUTLINE: This is a phase I, dose de-escalation study of sirolimus followed by a phase II
study.
Patients receive sirolimus orally (PO) two hours before or after grapefruit juice on day -2,
cisplatin intravenously (IV) on day 1 and gemcitabine hydrochloride IV over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients undergo cystectomy as clinically appropriate
after 1-4 courses of treatment.
After completion of study treatment, patients are followed up for 28 days.
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