Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer

Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated superficial recurrent bladder cancer refractory to standard intravesical therapy. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2). All patients with stage Ta will require documentation of high-grade histology. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy, including BCG, mitomycin, interferon or any combination thereof.
Age > 18 and must be able to read, understand and sign informed consent
Performance Status: ECOG 0,1 (See Appendix II )
Peripheral neuropathy: must be < grade 1

Hematologic-Inclusion within 2 weeks of start of treatment

Absolute neutrophil count > 1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count > 100,000/mm3

Hepatic-Inclusion within 2 weeks of entry

Total Bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤ 2.0 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends.
No intravesical therapy within 6 weeks of study entry
No prior radiation to the pelvis

Exclusion Criteria:

Prior systemic docetaxel or paclitaxel therapy.
Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded.
Concurrent treatment with any chemotherapeutic agent.
Women who are pregnant or lactating.
History of vesicoureteral reflux or an indwelling urinary stent.
Participation in any other research protocol involving administration of an investigational agent within 3 months prior to study entry aside from the phase I segment of this study.
History of neuropathy of any cause