Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Aditya Bagrodia (ucsd)Carissa Chu (ucsf)
Headshot of Carissa Chu
Carissa Chu

Description

Summary

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

Official Title

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Details

The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE

Keywords

Non-muscle-invasive Bladder Cancer, Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Gemcitabine, Docetaxel, BCG Vaccine, Bacillus Calmette Guerin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient must be > 18 years of age.
  • Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization.
  • Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease.
  • Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
  • Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization.

NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible.

  • Patient must not have pure squamous cell carcinoma or adenocarcinoma.
  • Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
  • Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patient must have ECOG Performance Status 0-2.
  • Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization):

Leukocytes ≥ 3,000/mcL Leukocytes: Date of Test: Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC: Date of Test: Platelets ≥ 70,000/mcL Platelets: Date of Test: Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin: Institutional ULN: Date of Test: AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST: Institutional ULN: Date of Test: ALT:__

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

You CAN'T join if...

  • Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.

NOTE: If a patient's renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable.

NOTE: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.

A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Patient of child bearing potential? ______ (Yes or No) Date of blood test or urine study:


  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition,patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment.
  • Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Woodland Memorial Hospital accepting new patients
    Woodland California 95695 United States
  • Los Angeles General Medical Center accepting new patients
    Los Angeles California 90033 United States
  • USC / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Mercy Cancer Center - Sacramento accepting new patients
    Sacramento California 95816 United States
  • Mercy Cancer Center - Elk Grove accepting new patients
    Elk Grove California 95758 United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez California 94553-3156 United States
  • Mercy Cancer Center - Carmichael accepting new patients
    Carmichael California 95608 United States
  • Mercy San Juan Medical Center accepting new patients
    Carmichael California 95608 United States

Lead Scientists at University of California Health

  • Aditya Bagrodia (ucsd)
    Associate Professor Of Clinical, Urology, Vc-health Sciences-schools. Authored (or co-authored) 248 research publications
  • Carissa Chu (ucsf)
    Assistant Professor, Urology, School of Medicine. Authored (or co-authored) 27 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ECOG-ACRIN Cancer Research Group
ID
NCT05538663
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 870 study participants
Last Updated