Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
New York University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01589094
First received: April 27, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.


Condition Intervention Phase
Bladder Cancer
Drug: Gemcitabine and Cisplatin (DD GC)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • pathologic response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.


Secondary Outcome Measures:
  • safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.

  • tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.

  • progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.


Estimated Enrollment: 46
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine and Cisplatin (DD GC)
This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.
Drug: Gemcitabine and Cisplatin (DD GC)
Patients will receive six cycles of GC administered every 14 days. Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Muscle invasive urothelial carcinoma of the bladder histologically confirmed at MSKCC or participating site ((Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA.)
  • Clinical stage T2-T4a N0/X M0 disease
  • Medically appropriate candidate for radical cystectomy, as per MSKCC or participating site
  • Karnofsky Performance Status ≥ 70%
  • Age ≥ 18 years of age
  • Required Initial Laboratory Values:
  • Absolute Neutrophil Count ≥ 1000 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin ≥ 9.0g/dL
  • Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution
  • Alkaline phosphatase ≤ 2.5 x ULN for the institution
  • Serum creatinine ≤ 1.5 mg/dL
  • Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 using the CKD-EPI equation: eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age
  • x 1.018 [if female] x 1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1
  • If female of childbearing potential, pregnancy test is negative

Exclusion Criteria:

  • Prior systemic chemotherapy (prior intravesical therapy is allowed)
  • Prior radiation therapy to the bladder
  • Evidence of NYHA functional class III or IV heart disease
  • Serious intercurrent medical or psychiatric illness, including serious active infection
  • Preexisting sensory grade ≥ 2 neuropathy
  • Preexisting grade ≥ 2 hearing loss
  • Major surgery or radiation therapy < 4 weeks of starting study treatment
  • Concomitant use of any other investigational drugs
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
  • Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. QOL, are allowed
  • Pregnancy or breast-feeding. Patients must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
  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: NCT01589094

Contacts
Contact: Dean Bajorin, MD 646-422-4333
Contact: Jonathan Rosenberg, MD 646-422-4461

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Dean Bajorin, MD    646-422-4333      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Dean Bajorin, MD    646-422-4333      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dean Bajorin, MD    646-422-4333      
Contact: Jonathan Rosenberg, MD    646-422-4461      
Principal Investigator: Dean Bajorin, MD         
New York University Recruiting
New York, New York, United States, 10010
Contact: Arjun Balar, MD         
Principal Investigator: Arjun Balar, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Dean Bajorin, MD    646-422-4333      
Memoral Sloan Kettering Cancer Center@Phelps Recruiting
Sleepy Hollow, New York, United States
Contact: Dean Bajorin, MD    646-422-4333      
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Matthew I Milowsky, MD         
Principal Investigator: Matthew Milowsky, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of North Carolina, Chapel Hill
New York University
Investigators
Principal Investigator: Dean Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01589094     History of Changes
Other Study ID Numbers: 12-071
Study First Received: April 27, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
CISPLATIN
GEMCITABINE
GM-CSF
radical cystectomy
12-071

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

ClinicalTrials.gov processed this record on September 18, 2014