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

Primary Purpose

Urologic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
S-8184 Paclitaxel Injectable Emulsion
Experimental Arm: TOCOSOL Paclitaxel
Sponsored by
Achieve Life Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Neoplasms focused on measuring Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Objective response rate; time to disease progression; duration of response; survival; toxicities

    Secondary Outcome Measures

    To determine time to disease progression

    Full Information

    First Posted
    April 23, 2002
    Last Updated
    June 2, 2009
    Sponsor
    Achieve Life Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00034177
    Brief Title
    Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Achieve Life Sciences

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urologic Neoplasms
    Keywords
    Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    S-8184 Paclitaxel Injectable Emulsion
    Intervention Type
    Drug
    Intervention Name(s)
    Experimental Arm: TOCOSOL Paclitaxel
    Intervention Description
    Doses of 80, 100 and 120mg/m2
    Primary Outcome Measure Information:
    Title
    Objective response rate; time to disease progression; duration of response; survival; toxicities
    Time Frame
    After all patients completed treatment
    Secondary Outcome Measure Information:
    Title
    To determine time to disease progression
    Time Frame
    After all patients have completed treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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