Status:
ACTIVE_NOT_RECRUITING
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder
Lead Sponsor:
Guarionex J. Decastro
Collaborating Sponsors:
Sanofi
Conditions:
Urothelial Carcinoma of the Urinary Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The investigators intend to evaluate the safety and toxicity profile of intravesically administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment refractory Transitional Cell...
Detailed Description
Nonsurgical treatment strategies for BCG refractory bladder cancer have failed to prove themselves as reliable options for increased survival among this subset of bladder cancer patients. For these pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2028
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02202772
Start Date
December 1 2014
End Date
April 1 2028
Last Update
February 24 2025
Active Locations (1)
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1
Columbia University Irving Medical Center - HIP
New York, New York, United States, 10032