- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077688
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
June 2, 2009 updated by: Achieve Life Sciences
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
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center/Greenbaum Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Washington
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Seattle, Washington, United States, 98109
- University of Washington/Seattle Cancer Care Alliance
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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 (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
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 |
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Objective response rate
|
Secondary Outcome Measures
Outcome Measure |
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Time to progression
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Time to treatment failure
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Progression free survival
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Overall survival at 2 years
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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
November 1, 2003
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
February 10, 2004
First Submitted That Met QC Criteria
February 13, 2004
First Posted (Estimate)
February 16, 2004
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
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Ureteral Diseases
- Urethral Diseases
- Neoplasms
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- SON-8184-1073
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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