Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

OBJECTIVES:

I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.

II. Assess the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Inclusion criteria

• Histologically confirmed transitional cell carcinoma (TCC) of the urothelium(renal pelvis, ureter, bladder, or urethra)

• Mixed histology carcinoma with a TCC component allowed
• Progressive regional disease
• Metastatic disease
• Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting

• May have included taxane-based therapy
• Measurable disease outside prior irradiation field
• Previously resected and irradiated CNS metastases with evidence of stable disease allowed
• Performance status - ECOG 0-2
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 2.5 times upper limit of normal
• Creatinine no greater than 1.5 mg/dL
• No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
• No uncontrolled congestive heart failure
• No ventricular dysrhythmia
• No active unresolved infection requiring parenteral antibiotics within the past week
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior systemic biologic response modifier therapy
• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy
• See Disease Characteristics
• At least 4 weeks since prior major surgery and recovered