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

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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

Inclusion Criteria:

- Muscle invasive urothelial carcinoma of the bladder histologically confirmed at MSKCC
or University of North Carolina at Chapel Hill

- Clinical stage T2-T4a N0/X M0 disease

- Medically appropriate candidate for radical cystectomy, as per MSKCC or University of
North Carolina at Chapel Hill Attending Urologic Oncologist

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic response rate

Outcome Description:

Defined as the absence of muscle invasive carcinoma (

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Dean Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Bladder Cancer
  • GM-CSF
  • radical cystectomy
  • 12-071
  • Urinary Bladder Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
University of North Carolina Chapel Hill, North Carolina  27599
New York University New York, New York  10016
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memorial Sloan-Kettering at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York