A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
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)
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
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