A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder
Inclusion Criteria:
- Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial
carcinoma of the bladder and be candidates for cystectomy following chemotherapy.
Tumor specimens must be available for assay of molecular markers (correlative
research).
- Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG)
criteria.
- Serum creatinine <2.0 mg/dl and/or creatinine clearance >40 ml/min.
- Granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl.
- Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, alkaline
phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl.
- Pre-existing peripheral neuropathy > grade 2
- Recovered from any effects of surgery.
- Women/men of reproductive potential may not participate unless they have agreed to
use an effective contraceptive method. Women with reproductive potential must have a
negative pregnancy test.
Exclusion Criteria:
- Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical
chemotherapy allowed.)
- Pre-existing peripheral neuropathy > grade 2
- Prior malignancy [except for adequately treated basal cell (or squamous cell) skin
cancer, in situ cervical cancer or other cancer for which the patient has been
disease free for 2 years]
- Unresolved bacterial infection requiring active treatment with antibiotics.
(Treatment may begin at the conclusion of antibiotic therapy.)
- Pregnant or lactating women may not participate.