A PHASE 2 MULTICENTER EVALUATION OF THESAFETY AND EFFICACY OF TOCOSOL™ PACLITAXEL(S-8184 PACLITAXEL INJECTABLE EMULSION) INPATIENTS WITH METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE TRANSITIONAL CELL CARCINOMA OF THE UROTHELIUM

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 44

Inclusion Criteria

a)Histologic diagnosis of TCC of the urothelium including bladder, renal pelvis, ureter, or urethra. Patients with mixed tumors (i.e. tumors containing elements of squamous cell or adenocarcinoma in addition to transitional cell carcinoma) are eligible, but patients with pure non-transitional cell carcinoma are not.
b)Stage IV disease, i.e., metastatic (any T any N M1) or locally advanced (T4b N0 M0 or any T N1-3 M0) disease deemed incurable by surgical resection
c)One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease. (Intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy.) Prior chemotherapy should have included a minimum of two cycles of standard dose MVAC (methotrexate, vinblastine, Adriamycin and cisplatin) or cis/carboplatin and gemcitabine. Other prior chemotherapy regimens of presumed comparable efficacy and dose intensity may be acceptable if approved by the Sonus Medical Director or his designee.
d)Adequate hematologic function (ANC > 1500 cells/mm3 and platelet count >100,000/mm3)
e)Serum creatinine < 2.0 mg/dL
f)Total bilirubin < 1.5 mg/dL
g)SGOT and SGPT < 3 times the upper limit of institutional normal values
h)PT (INR) and PTT within institutional laboratory normal range
i)Karnofsky performance status of 60-100% (see Appendix 2)
j)At lease one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria (see Section 9.2, Appendix 4 and Reference 14)
k)A signed IRB / Ethics Committee-approved Informed Consent
l)Life expectancy of at least 12 weeks
m)18 years of age or older
n)Fully recovered from any previous surgery (at least 4 weeks since major surgery)
o)Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and females, unless surgically sterilized or post-menopausal females).
p)Agree not to take vitamin E supplementation while receiving study medication.
q)Willing to participate in requested follow-up evaluations for 1 month after completion of treatment, or until treatment-related toxicities have resolved or clinically stabilized.
r)Willing to permit treating physicians to provide information to the Sponsor regarding disease status and survival for 2 years after the first dose of study drug

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Prior taxane-containing chemotherapy including Taxol (paclitaxel) or generic equivalent, or Taxotere (docetaxel)
b)Peripheral neuropathy NCI-CTC grade 2 or greater
c)Wide-field radiation (radiation to more than 20% of the marrow bearing skeleton), cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
d)An investigational agent within 4 weeks of first dose of study drug
e)Concurrent anticonvulsants known to induce P450 isoenzymes
f)Patients who are pregnant or lactating
g)A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
h)Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC. (Patients with these findings in addition to a measurable target lesion are eligible.)
i)Brain metastasis
j)Active bowel obstruction
k)Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol. (Any ambiguous clinical circumstances must be reviewed and approved by a Sonus Medical Director).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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