Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma

Exclusion Criteria

• •Concomitant bladder urothelial carcinoma is acceptable if it is organ confined and surgically resectable.
• •Presence of carcinoma in situ (CIS)
• •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 4.0 grade ≥ 2.
• •Uncontrolled hypertension (\>150/100 mmHg despite optimal medical therapy).
• •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. Patients with HIV but no evidence of AIDS will be considered candidates.
• •Concurrent treatment on another clinical trial involving an intervention which may affect the primary endpoint. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
• •Ongoing treatment with therapeutic doses of warfarin or low molecular weight heparin (low dose warfarin up to 2 mg po daily or use of subcutaneous low molecular weight heparin for thromboembolic prophylaxis is allowed).
• •Pregnancy or breast-feeding. Patients must be surgically sterile or be 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 MSKCC and participating site PI. Male patients must be surgically sterile or agree to use effective contraception