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

October 11, 2019

Research & Trial Information

SCHEMA A031701

Protocol#: Alliance – A031701

Cancer Type: Bladder

Patient Eligibility:

  1. 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 EUA. The diagnostic TURBT sample must have been obtained within 60 days prior to registration.
  2. 10-20 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 10-20 slides, for a total of 12-22 unstained slides. An FFPE block is also acceptable.
  3. Clinical stage T2-T4aN0/xM0 disease.
  4. Medically appropriate candidate for radical cystectomy as assessed by surgeon.
  5. No concomitant multifocal carcinoma in situ; a single focus is allowed.
  6. One focus of muscle-invasive bladder cancer and/or a tumor <5 cm in size.
  7. No clinical or radiographic evidence for locally advanced or metastatic disease.
  8. 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 x6 treatments; BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed).
  9. No prior radiation therapy to the bladder.
  10. No major surgery or radiation therapy <4 weeks of registration.
  11. Age ≥ 18 years.
  12. ECOG Performance Status 0-1.
  13. Step 2 Patient Registration Eligibility Criteria:
  14. Patients must have completed 4 or more cycles of protocol-directed chemotherapy.
  15. Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration):
  16. Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pretreatment TURBT DNA.
  17. Cystoscopy and imaging performed to determine stage/treatment assignment.

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