Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.