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Trial Title: Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder

NCT ID: NCT02202772

Condition: Urothelial Carcinoma of the Urinary Bladder

Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Gemcitabine
Cisplatin

Conditions: Keywords:
Urothelial
Cisplatin
Gemcitabine
Cabazitaxel
Bladder
Carcinoma
Bacillus Calmette-Guerin
Intravesical
Recurrent
Non-muscle
Invasive
Cancer

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cabazitaxel
Description: Intravesical instillation of the Cabazitaxel for 2 hours
Arm group label: Gem and High Cab
Arm group label: Gem and Low Cab
Arm group label: Gem, High Cab, High Cis
Arm group label: Gem, High Cab, Mod Cis
Arm group label: Gem, High Cab, and Low Cis

Other name: Jevtana

Intervention type: Drug
Intervention name: Gemcitabine
Description: Intravesical instillation of Gemcitabine for 2 hours
Arm group label: Gem and High Cab
Arm group label: Gem and Low Cab
Arm group label: Gem, High Cab, High Cis
Arm group label: Gem, High Cab, Mod Cis
Arm group label: Gem, High Cab, and Low Cis

Other name: Gemzar

Intervention type: Drug
Intervention name: Cisplatin
Description: Intravesical installation of Cisplatin for 2hours
Arm group label: Gem, High Cab, High Cis
Arm group label: Gem, High Cab, Mod Cis
Arm group label: Gem, High Cab, and Low Cis

Other name: Platinol, Platinol-AQ

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 Carcinoma.The investigators propose to conduct a combined phase I trial to assess the safety, toxicity, and efficacy of a novel multidrug intravesical regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.

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 patients, removal of the bladder with all the associated perioperative risks and the subsequent reduction of quality of life, remains the only option. Prior attempts at second line treatments have included intravesical (within the bladder) monotherapy with a range of drugs including Gemcitabine and Paclitaxel (a taxane, similar to Cabazitaxel). These drugs have shown some potential improvement for a small number of patients Given the synergy of systemic chemotherapy, it is believed that a multidrug regimen would allow for further improvement in survival among these patients.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Columbia University Medical Center- HIP

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Guarionex Decastro, MD

Phone: 212-305-0114
Email: gjd16@cumc.columbia.edu

Investigator:
Last name: James McKiernan, MD
Email: Sub-Investigator

Investigator:
Last name: Guarionex Decastro, MD
Email: Principal Investigator

Investigator:
Last name: Christopher Anderson, MD
Email: Sub-Investigator

Start date: December 1, 2014

Completion date: December 2024

Lead sponsor:
Agency: James M. McKiernan
Agency class: Other

Collaborator:
Agency: Sanofi
Agency class: Industry

Source: Columbia University

Record processing date: ClinicalTrials.gov processed this data on March 31, 2022

ClinicalTrials.gov page: https://clinicaltrials.gov/show/NCT02202772
https://cancer.columbia.edu/

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