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

Urologic Neoplasms Clinical Trial

Official title:

Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034177
• Other study ID #: SON-8184-1065
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2002
• Last updated: June 2, 2009
• Start date: April 2002
• Est. completion date: September 2007

Study information

• Verified date: June 2009
• Source: OncoGenex Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urologic Neoplasms

Intervention

Drug:
• S-8184 Paclitaxel Injectable Emulsion

• Experimental Arm: TOCOSOL Paclitaxel
Doses of 80, 100 and 120mg/m2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OncoGenex Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate; time to disease progression; duration of response; survival; toxicities		After all patients completed treatment	No
Secondary	To determine time to disease progression		After all patients have completed treatment	No