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

This study has been completed.
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034177
First received: April 23, 2002
Last updated: June 2, 2009
Last verified: June 2009

April 23, 2002
June 2, 2009
April 2002
September 2007   (final data collection date for primary outcome measure)
Objective response rate; time to disease progression; duration of response; survival; toxicities [ Time Frame: After all patients completed treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00034177 on ClinicalTrials.gov Archive Site
To determine time to disease progression [ Time Frame: After all patients have completed treatment ] [ Designated as safety issue: No ]
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Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urologic Neoplasms
  • Drug: S-8184 Paclitaxel Injectable Emulsion
  • Drug: Experimental Arm: TOCOSOL Paclitaxel
    Doses of 80, 100 and 120mg/m2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00034177
SON-8184-1065
Not Provided
Monica Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
OncoGenex Pharmaceuticals
Not Provided
Not Provided
OncoGenex Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP