A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (DDGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. 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, by stopping them from dividing, or by stopping them from spreading.

<>Key Eligiblity:
•Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration
•20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable
•Clinical stage T2-T4aN0/xM0 disease
•Medically appropriate candidate for radical cystectomy as assessed by surgeon
•No concomitant multifocal carcinoma in situ; a single focus is allowed
•One focus of muscle-invasive bladder cancer and/or a tumor < 5 cm in size
•No clinical or radiographic evidence for locally advanced or metastatic disease
•No prior anti-PD-1, anti PD-L1 therapies, or systemic chemotherapy (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x 6 treatments; BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed)
•No prior radiation therapy to the bladder
•No major surgery or radiation therapy =< 4 weeks of registration
Phase II
Alison Conlin, M.D.

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.