Condition: Urothelial Carcinoma of the Urinary Bladder

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02202772

Sponsor: James M. McKiernan

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patients must have a histologically confirmed diagnosis of non- muscle invasive urothelial carcinoma of the bladder at the study institution prior to the beginning of the study. This includes patients with:
• High grade Ta papillary lesion(s)
• High or low grade T1 papillary lesion(s)
• Carcinoma In Situ (CIS), with or without Ta or T1 papillary tumor(s) of any grade The patient must have Bacillus Calmette-Guerin (BCG) refractory or recurrent non-muscle invasive bladder cancer
• Refractory disease is defined as evidence of persistent high risk bladder cancer (high grade Ta, T1 and/or CIS) at the first cystoscopic exam after the initial 6 week induction course of BCG or at the 6 month cystoscopic exam.
• Recurrent disease is defined as reappearance of disease after achieving a tumor- free status by 6 months following a full induction course of BCG with or without maintenance BCG. Participants must have recurred within 18 months following the last dose of BCG.
• Low-grade superficial (Ta) disease will not be considered recurrent.
• Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy that must include a minimum of one induction course of BCG and may also include prior exposure to mitomycin, interferon, single agent gemcitabine or taxane therapy or maintenance.
• Patients must be eligible for radical cystectomy and refuse this standard of care treatment or not be a surgical candidate for radical cystectomy based on other comorbidities.
• All grossly visible disease in the bladder must be fully resected and pathologic stage will be confirmed at the study institution.
• Patients enrolled in other clinical trials must have received their last treatment at least 6 weeks prior to enrollment.
• Age > 18 and must be able to read, understand and sign informed consent
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance Status: ECOG of 0 or 1 including patients who are not surgical candidates due to comorbid conditions.
• Women of childbearing potential must have a negative pregnancy test.
• All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), Birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends.
• No experimental intravesical therapy within 6 weeks of study entry

Exclusion Criteria:

• History of severe hypersensitivity reaction (≥grade 3) to docetaxel
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on I these treatments)
• Concurrent malignancy diagnosed within 6 months of entry to the study.
• Concurrent treatment with any systemic chemotherapeutic agent.
• Inadequate organ and bone marrow function as evidenced by:
• Hemoglobin: less than 8.0 g/dL
• Absolute neutrophil count: less than 1.5 x 10^9/L
• Platelet count: less than 80x 10^9/L
• Aspartate Aminotransferase Test (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT) and/or ( Alanine Aminotransferase Test (ALT)/ Serum Glutamic Pyruvic Transaminase (SGPT) >2.5 x upper limit of normal (ULN);
• Total bilirubin >1.5 x ULN
• Serum creatinine >2 x ULN. If creatinine 1.5
• 2.0 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and patients with creatinine clearance <30 mL/min should be excluded.
• Women who are pregnant or lactating.
• Documented history of vesicoureteral reflux or an indwelling urinary stent.
• Participation in any other research protocol involving administration of an investigational agent within 6 weeks prior to study entry.
• No Institutional Review Board (IRB) approved signed consent form

View trial on ClinicalTrials.gov