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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034177
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : June 4, 2009
Information provided by:
Achieve Life Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Urologic Neoplasms Drug: S-8184 Paclitaxel Injectable Emulsion Drug: Experimental Arm: TOCOSOL Paclitaxel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2002
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Intervention Details:
    Drug: S-8184 Paclitaxel Injectable Emulsion Drug: Experimental Arm: TOCOSOL Paclitaxel
    Doses of 80, 100 and 120mg/m2

Primary Outcome Measures :
  1. Objective response rate; time to disease progression; duration of response; survival; toxicities [ Time Frame: After all patients completed treatment ]

Secondary Outcome Measures :
  1. To determine time to disease progression [ Time Frame: After all patients have completed treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Monica Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals Identifier: NCT00034177     History of Changes
Other Study ID Numbers: SON-8184-1065
First Posted: April 25, 2002    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Achieve Life Sciences:
Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urogenital Neoplasms
Neoplasms by Site
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action