- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202772
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder (CGC)
A Phase I/II 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center - HIP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gem and Low Cab
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 2.5mg/100ml; 1 time a week for 6 weeks; 2 hours
|
Intravesical instillation of the Cabazitaxel for 2 hours
Other Names:
Intravesical instillation of Gemcitabine for 2 hours
Other Names:
|
Experimental: Gem and High Cab
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours
|
Intravesical instillation of the Cabazitaxel for 2 hours
Other Names:
Intravesical instillation of Gemcitabine for 2 hours
Other Names:
|
Experimental: Gem, High Cab, and Low Cis
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 66mg/100ml; 1 time a week for 6 weeks; 2 hours
|
Intravesical instillation of the Cabazitaxel for 2 hours
Other Names:
Intravesical instillation of Gemcitabine for 2 hours
Other Names:
Intravesical installation of Cisplatin for 2hours
Other Names:
|
Experimental: Gem, High Cab, Mod Cis
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 80mg/100ml; 1 time a week for 6 weeks; 2 hours
|
Intravesical instillation of the Cabazitaxel for 2 hours
Other Names:
Intravesical instillation of Gemcitabine for 2 hours
Other Names:
Intravesical installation of Cisplatin for 2hours
Other Names:
|
Experimental: Gem, High Cab, High Cis
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 100mg/100ml; 1 time a week for 6 weeks; 2 hours
|
Intravesical instillation of the Cabazitaxel for 2 hours
Other Names:
Intravesical instillation of Gemcitabine for 2 hours
Other Names:
Intravesical installation of Cisplatin for 2hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1a/1b: The number of serious adverse events associated with therapy of intravesically administered Cabazitaxel, Gemcitabine, and Cisplatin.
Time Frame: 6 weeks from baseline
|
The investigator is measuring safety by looking at the number of events that occur during the study
|
6 weeks from baseline
|
Phase 2: The number of complete responders after completion of six weeks of intravesically
Time Frame: 6 weeks from baseline
|
The investigator is measuring efficacy by the number of complete responders to the treatment
|
6 weeks from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guarionex DeCastro, MD, Columbia University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Cisplatin
- Gemcitabine
Other Study ID Numbers
- AAAM8506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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