Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Overview
- Phase
- Phase 2
- Intervention
- Sunitinib
- Conditions
- Bladder Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 18
- Locations
- 5
- Primary Endpoint
- The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your tumor before you undergo surgery for your bladder cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed muscle invasive transitional cell carcinoma of the bladder at MSKCC.
- •Clinical stage T2-T4a N0/X M0 disease.
- •Medically appropriate candidate for radical cystectomy as per MSKCC attending urologic oncologist.
- •Karnofsky Performance Status ≥ 70%.
- •Age ≥ 18 years of age.
- •Required Initial Laboratory Values:
- •Absolute neutrophil count ≥ 1500 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 3 neuropathy
- •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, or pulmonary embolism.
- •Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade ≥
Arms & Interventions
Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Intervention: Sunitinib
Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Intervention: Gemcitabine
Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Intervention: cisplatin
Outcomes
Primary Outcomes
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
Time Frame: 2 years
Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Secondary Outcomes
- The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.(2 years)
- The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.(2 years)