Clinical Trials Directory

Trials / Completed

CompletedNCT01938573

Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer

A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
21 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGCisplatinGiven IV
DRUGGemcitabine HydrochlorideGiven IV
DRUGSirolimusGiven PO
PROCEDURECystectomyUndergo cystectomy when appropriate

Timeline

Start date
2013-10-01
Primary completion
2016-08-18
Completion
2016-08-18
First posted
2013-09-10
Last updated
2017-10-20
Results posted
2017-10-20

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01938573. Inclusion in this directory is not an endorsement.