Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT03912818
Phase
PHASE2
Status
Terminated

Conditions

  • Bladder Adenocarcinoma
  • Bladder Mixed Adenocarcinoma
  • Bladder Squamous Cell Carcinoma
  • Bladder Urothelial Carcinoma
  • Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
  • Infiltrating Bladder Urothelial Carcinoma With Giant Cells
  • Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
  • Infiltrating Bladder Urothelial Carcinoma With Trophoblastic Differentiation
  • Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant
  • Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
  • Infiltrating Bladder Urothelial Carcinoma, Nested Variant
  • Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • Cisplatin — DRUG
    Given IV
  • Cystectomy — PROCEDURE
    Undergo cystectomy
  • Doxorubicin — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IV
  • Vinblastine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Apr 10, 2019
Status verified
Aug 2023
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort II (durvalumab, cis-gem)
    Durvalumab (MEDI4736), at 1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Cisplatin 70 mg/m2 on Cycle Day 2, and gemcitabine 1,000 mg/m2 on Cycle Day 1 and Day 8 in 21 day cycles (3 weeks). Patients undergo cystectomy within 6 weeks.
  • Experimental: Cohort III (Durvalumab, carbo-gem)
    Durvalumab (MEDI4736), at 1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Carboplatin: AUC 5 on Cycle Day 1 and gemcitabine 1,000 mg/m2 on Cycle Day 1 and Day 8 in 21 day cycles (3 weeks). Patients undergo cystectomy within 6 weeks.
  • Experimental: Cohort I (durvalumab, DD MVAC)
    Durvalumab (MEDI4736), at1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Dose Dense Methotrexate, Vinblastine, Doxorubicin, Cisplatin (DD MVAC), in 14 day cycles (2 weeks), Methotrexate 30 mg/m2 on Cycle Day 1, Vinblastine 3 mg/m2 on Cycle Day 2, Doxorubicin 30 mg/m2 on Cycle Day 2 and Cisplatin 70 mg/m2 on Cycle Day 2. Patients undergo cystectomy within 6 weeks.

Primary Outcome Measure

Incidence of Grade 3-5 Adverse Events [ Time Frame: At 120 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Institute Palo Alto· Palo Alto, CA

Related Studies