A Phase I Trial for the Use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment of BCG-Refractory Non-muscle Invasive Urothelial Carcinoma of the Bladder Cancer


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


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