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TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium | Clinical Trials | Clareo Health

COMPLETEDPHASE2

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

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

NCT00077688•Achieve Life Sciences

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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
+1 more criteria

Locations (3)

University of Maryland Medical Center/Greenbaum Cancer Center

Baltimore, Maryland, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

November 1, 2003

Completion Date

September 1, 2007

Last Updated

June 4, 2009

Enrollment

Estimated participants

Conditions

Bladder NeoplasmsUreteral NeoplasmsUrethral NeoplasmsCarcinoma, Transitional Cell

Interventions

TOCOSOL Paclitaxel

DRUG

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

NCT05316155

Non-Muscle Invasive Bladder Neoplasms

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RECRUITINGPHASE1/PHASE2

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

NCT07222488

Bladder CancerUrinary Bladder Neoplasms

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Inclusion Criteria

Exclusion Criteria

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

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