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



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:April 2012
End Date:August 2018

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

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.


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.
We found this trial at
8
sites
70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Basking Ridge, New Jersey 07920
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Basking Ridge, NJ
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Rockville Centre, NY
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Sleepy Hollow, NY
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