A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
- Patients must have histological or cytological diagnosis of urothelial carcinoma.
Mixed histologies are permitted as long as transitional cell carcinoma is the major
component (i.e. >50% of the pathologic specimen). Pure or predominant squamous cell
carcinomas are not permitted.
- Patients with transitional cell carcinomas of the renal pelvis and ureter are
- Patients must have metastatic or locally advanced unresectable disease.
- Patients must have received one and only one prior chemotherapeutic regimen which
included a platinum (at least one cycle) for metastatic/recurrent disease.
Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if
the patient progressed within 12 months of the last dose.
- Neoadjuvant/adjuvant chemotherapy (with or without a taxane) is permitted if
registration is greater than 12 months since the last dose (patients must then have
received one platinum containing regimen in the metastatic setting)
- ECOG performance status <= 2.
- Estimated life expectancy of >12 weeks.
- Patients must have measurable disease according to RECIST criteria.
- If female of childbearing potential, pregnancy test is negative within 72 hours
priors to first dose of study drug.
- If fertile, patient agrees to use an effective method of contraception to avoid
pregnancy for the duration of the study.
- Adequate organ function; Absolute neutrophil count >1.5 x 109/L. Platelet count >100
x109/L. Hemoglobin >90 g/L. Total bilirubin <1.5x upper limit of normal.
Transaminases <3x upper limit of normal (<5x if liver metastasis are present)
Calculated creatinine clearance >40 ml/min (Cockcroft & Gault formula)
- Able to give informed consent.
- Prior taxane therapy for metastatic disease (or > 12 months since a taxane-containing
neoadjuvant or adjuvant chemotherapy).
- Pre-existing peripheral neuropathy >1 by NCI-CTC criteria.
- Pregnant or lactating females.
- Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted
if both known lesions and medications e.g. steroids for that indication are stable).
- History of serious or concurrent illness that might be aggravated by study treatment.
- History of class II-IV congestive heart failure.
- Other malignancies except adequately controlled basal cell carcinoma of the skin or
carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason <7 PSA
<10ng/ml) or any other tumor within 5 years prior to enrollment.
- Other investigational therapy or radiation therapy within 30 days before
- Patients not willing to employ adequate contraception for the duration of the study.