This trial is active, not recruiting.

Condition bladder cancer
Treatment gemcitabine and cisplatin (dd gc)
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator University of North Carolina, Chapel Hill
Start date April 2012
End date April 2017
Trial size 46 participants
Trial identifier NCT01589094, 12-071


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
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)

Primary Outcomes

pathologic response rate
time frame: 1 year

Secondary Outcomes

time frame: 1 year
time frame: 1 year
progression-free survival
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
Principal investigator Dean Bajorin, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.