Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer
About this trial
This is an interventional treatment trial for Distal Urethral Cancer
Eligibility Criteria
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
Sites / Locations
- Eastern Cooperative Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.