Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
CISPLATIN, GEMCITABINE, GM-CSF, radical cystectomy, 12-071
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine and Cisplatin (DD GC)
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
New York University
New York, New York, United States
Status: Recruiting
Contact: Arjun Balar, MD
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Dean Bajorin, MD - 646-422-4333
University of North Carolina
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Matthew I Milowsky, MD
Start Date
April 2012
Completion Date
April 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page