Overview

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

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Achieve Life Sciences
OncoGenex Technologies
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
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