- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034177
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
June 2, 2009 updated by: Achieve Life Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
27
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate; time to disease progression; duration of response; survival; toxicities
Time Frame: After all patients completed treatment
|
After all patients completed treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine time to disease progression
Time Frame: After all patients have completed treatment
|
After all patients have completed treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
April 23, 2002
First Submitted That Met QC Criteria
April 24, 2002
First Posted (Estimate)
April 25, 2002
Study Record Updates
Last Update Posted (Estimate)
June 4, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SON-8184-1065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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