Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology B… (NCT03912818) | Clinical Trial Compass
TerminatedPhase 2
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
Stopped: Difficulty with enrollment
United States7 participantsStarted 2019-04-10
Plain-language summary
This phase II trial studies the side effects of durvalumab and chemotherapy before surgery in treating patients with variant histology bladder cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, cisplatin, gemcitabine, and carboplatin, 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 durvalumab in addition to standard chemotherapy may lead to better outcomes in patients with variant histology bladder cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed informed consent.
* Eastern Collaborative Oncology Group (ECOG) performance status score of 0 or 1.
* Body weight \> 30 kg.
* Absolute neutrophil count (ANC) \>= 1500 mm\^3 (within 28 days before the first study treatment).
* Hemoglobin \>= 9.0 g/dL (within 28 days before the first study treatment).
* Platelet count \>= 100,000 per mm\^3 (within 28 days before the first study treatment).
* Serum bilirubin =\< 1.5 X upper limit of normal (ULN) (within 28 days before the first study treatment). Subjects with Gilbert's syndrome will be considered after consultation with the principal investigator (PI).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 X ULN (within 28 days before the first study treatment).
* For subjects who will be treated with dose dense methotrexate, vinblastine, doxorubicin, and cisplatin (DD MVAC) or cisplatin and gemcitabine (CG), creatinine clearance \>= 50 mL/min as measured based on Cockcroft-Gault glomerular filtration rate estimation (within 28 days before the first study treatment).
* For subjects who will be treated with carboplatin and gemcitabine (Carbo Gem), creatinine clearance \>= 30 mL/min as measured based on Cockcroft-Gault glomerular filtration rate estimation (within 28 days before the first study treatment).
* Anticipated life expectancy of \>= 12 weeks as assessed by the investigator.
* Histologically proven carcinoma of the bladder of variant urothelial carcinoma histologies whi…