Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine and Cisplatin (DD GC)
- Conditions
- Bladder Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 51
- Locations
- 8
- Primary Endpoint
- Pathologic Response Rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility 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
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
Arms & Interventions
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.
Intervention: Gemcitabine and Cisplatin (DD GC)
Outcomes
Primary Outcomes
Pathologic Response Rate
Time Frame: 1 year
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 Outcomes
- Number of Participants With Toxicity(1 year)
- 2 Year Recurrence Free Survival (RFS) Rate for Responders(2 years)
- 2 Year Recurrence Free Survival (RFS) Rate for Nonresponders(2 years)