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

Sponsored by:	OncoGenex Pharmaceuticals
Information provided by:	OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00034177

Purpose

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.

Condition	Intervention	Phase
Urologic Neoplasms	Drug: S-8184 Paclitaxel Injectable Emulsion Drug: Experimental Arm: TOCOSOL Paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:

Objective response rate; time to disease progression; duration of response; survival; toxicities [ Time Frame: After all patients completed treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine time to disease progression [ Time Frame: After all patients have completed treatment ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	April 2002
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Doses of 80, 100 and 120mg/m2

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	OncoGenex Pharmaceuticals ( Monica Krieger, VP Regulatory Affairs )
Study ID Numbers:	SON-8184-1065
Study First Received:	April 23, 2002
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00034177 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by OncoGenex Pharmaceuticals:

Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

Study placed in the following topic categories:

Urinary Tract Neoplasm
Paclitaxel
Tubulin Modulators
Urogenital Neoplasms
Antimitotic Agents
Urologic Neoplasms

Carcinoma, Transitional Cell
Antineoplastic Agents, Phytogenic
Recurrence
Transitional Cell Carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Urogenital Neoplasms
Antimitotic Agents
Carcinoma, Transitional Cell
Urologic Neoplasms
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009