TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium - Tabular View

Tracking Information
First Received Date ^ICMJE	February 10, 2004
Last Updated Date	June 2, 2009
Start Date ^ICMJE	November 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: January 31, 2006)	Objective response rate
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00077688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 31, 2006)	Time to treatment failure Time to progression Progression free survival Overall survival at 2 years
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
Official Title ^ICMJE	A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
Brief Summary	Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bladder Neoplasms Ureteral Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell
Intervention ^ICMJE	Drug: TOCOSOL Paclitaxel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	44
Completion Date	September 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra Stage IV disease One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease Adequate hematologic function (ANC >/= 1500 cells/mm3 & platelet count >/= 100,000/mm3) Serum creatinine </= 2.0 mg/dL Total bilirubin </= 1.5 mg/dL SGOT & SGPT </= 3 times upper limit of institutional normal values PT (INR) & PTT within institutional lab normal range Karnofsky performance status of 60-100% At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria Signed IRB/EC approved Informed Consent Life expectancy of at least 12 weeks 18 years of age or older Fully recovered from any previous surgery Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females) Agree not to take vitamin E supplementation while receiving study medication Willing to participate in requested follow-up evaluations Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug Exclusion Criteria: Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel) Peripheral neuropathy NCI-CTC grade 2 or greater Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug An investigational agent within 4 weeks of first dose of study drug Concurrent anticonvulsants known to induce P450 isoenzymes Patients who are pregnant or lactating 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 Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC Brain metastasis Active bowel obstruction Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00077688
Responsible Party
Study ID Numbers ^ICMJE	SON-8184-1073
Study Sponsor ^ICMJE	OncoGenex Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OncoGenex Pharmaceuticals
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP