Trial record 2 of 64 for:    bladder cancer and columbia

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Columbia University
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
James M. McKiernan, Columbia University
ClinicalTrials.gov Identifier:
NCT02202772
First received: July 25, 2014
Last updated: January 28, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Urothelial Carcinoma of the Urinary Bladder
Drug: Cabazitaxel
Drug: Gemcitabine
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • The number of serious adverse events associated with therapy of intravesically administered CGC. [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: Yes ]
    The invesitgator is measuring safety by looking at the number of events that occur during the study


Secondary Outcome Measures:
  • The number of complete responders after completion of six weeks of intravesically administered Cabazitaxel, Gemcitabine, and Cisplatin. [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: Yes ]
    The investigator is measuring efficacy by the number of complete responders to the treatment


Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Cabazitaxel
Intravesical instillation of the Cabazitaxel for 2 hours
Other Name: Jevtana
Drug: Gemcitabine
Intravesical instillation of Gemcitibine for 2 hours
Other Name: Gemzar
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
Drug: Cabazitaxel
Intravesical instillation of the Cabazitaxel for 2 hours
Other Name: Jevtana
Drug: Gemcitabine
Intravesical instillation of Gemcitibine for 2 hours
Other Name: Gemzar
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
Drug: Cabazitaxel
Intravesical instillation of the Cabazitaxel for 2 hours
Other Name: Jevtana
Drug: Gemcitabine
Intravesical instillation of Gemcitibine for 2 hours
Other Name: Gemzar
Drug: Cisplatin
Intravesical installation of Cisplatin for 2hours
Other Name: Platinol, Platinol-AQ
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
Drug: Cabazitaxel
Intravesical instillation of the Cabazitaxel for 2 hours
Other Name: Jevtana
Drug: Gemcitabine
Intravesical instillation of Gemcitibine for 2 hours
Other Name: Gemzar
Drug: Cisplatin
Intravesical installation of Cisplatin for 2hours
Other Name: Platinol, Platinol-AQ
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
Drug: Cabazitaxel
Intravesical instillation of the Cabazitaxel for 2 hours
Other Name: Jevtana
Drug: Gemcitabine
Intravesical instillation of Gemcitibine for 2 hours
Other Name: Gemzar
Drug: Cisplatin
Intravesical installation of Cisplatin for 2hours
Other Name: Platinol, Platinol-AQ

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 grade bladder cancer (Ta, T1 and/or CIS) at the first cystoscopic exam after the initial 6 week induction course of Bacillus Calmette-Guerin (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 Bacillus Calmette-Guerin (BCG) with or without maintenance Bacillus Calmette-Guerin (BCG). Participants must have recurred within 18 months following the last dose of Bacillus Calmette-Guerin (BCG).

    o Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy that must include a minimum of one induction course of Bacillus Calmette-Guerin (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: Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (See Appendix I) including patients who are not surgical candidates due to comorbid conditions.
  • Peripheral neuropathy: must be < grade 1
  • 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., 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) (see Appendix IV)
  • 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 9.0 g/dL (Normal Range: Male: 13.5-17.5g/dL Female: 12.0-16.0 g/dL)
    • Absolute neutrophil count: less than 1.5 x 10^9/L,
    • Platelet count: less than 100 x 10^9/L (Normal Range: 150-400 x 10^9)
    • Aspartate Aminotransferase Test (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT) and/or ( Alanine Aminotransferase Test (ALT)/ Serum Glutamic Pyruvic Transaminase (SGPT) >2.5 x ULN;
    • Total bilirubin >1.0 x ULN,(Normal Range: Bilirubin, serum (adult) 0.1-1.0 mg/dL)
    • Serum creatinine >1.5 x ULN. (Normal Range: 0.6-1.2mg/dL)
  • 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 IRB approved signed consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02202772

Contacts
Contact: James McKiernan, MD 212-305-5526
Contact: Jamie Pak 212-305-6665 jsp2187@columbia.edu

Locations
United States, New York
Columbia University Medical Center- HIP Recruiting
New York, New York, United States, 10032
Contact: Jamie Pak    212-305-6665    jsp2187@columbia.edu   
Principal Investigator: James McKiernan, MD         
Sub-Investigator: Guarionex J DeCastro, MD         
Sponsors and Collaborators
Columbia University
Sanofi
Investigators
Principal Investigator: James McKiernan, MD Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: James M. McKiernan, Chairman of Urology, Columbia University
ClinicalTrials.gov Identifier: NCT02202772     History of Changes
Other Study ID Numbers: AAAM8506
Study First Received: July 25, 2014
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Bladder
Cancer
Urothelial
Cisplatin
Gemcitabine
Cabazitaxel
Carcinoma
Bacillus Calmette-Guerin
Intravesical
Recurrent
Non-muscle
Invasive

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Diseases
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 30, 2015