Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium

Achieve Life Sciences

Status and phase

Completed

Phase 2

Conditions

Urologic Neoplasms

Treatments

Drug: Experimental Arm: TOCOSOL Paclitaxel

Drug: S-8184 Paclitaxel Injectable Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00034177

SON-8184-1065

Details and patient eligibility

About

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.

Full description

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
Adult (18 years of age or older) patients
Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
Serum creatinine less than 2.0 mg/dL
Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
ECOG performance status of 0 - 2
Bidimensional measurable disease
Patients who have signed an IRB / Ethics Committee approved informed consent
Life expectancy at least 12 weeks
Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion criteria

Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
Patients with intracranial metastases
Females who are pregnant or lactating
Patients with peripheral neuropathy NCI-CTC grade 2 or greater
Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
Patients who have had an investigational agent within 4 weeks of study entry
Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes