Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+16

+ Urinary Bladder Diseases

+ Urinary Bladder Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorAchieve Life Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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

Official TitleA 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 
NCT00077688
Principal SponsorAchieve Life Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsCarcinomaCarcinoma, Transitional CellFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUreteral DiseasesUreteral NeoplasmsUrethral DiseasesUrethral NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of Maryland Medical Center/Greenbaum Cancer Center

Baltimore, United StatesSee the location
Suspended

Cleveland Clinic Foundation

Cleveland, United States
Suspended

University of Washington/Seattle Cancer Care Alliance

Seattle, United States
Completed3 Study Centers