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

Purpose

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

Condition	Intervention	Phase
Bladder Neoplasms Ureteral Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell	Drug: TOCOSOL Paclitaxel	Phase II

Genetics Home Reference related topics:

bladder cancer

MedlinePlus related topics:

Bladder Cancer Cancer

ChemIDplus related topics:

Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Sonus Pharmaceuticals:

Primary Outcome Measures:

Objective response rate

Secondary Outcome Measures:

Time to treatment failure
Time to progression
Progression free survival
Overall survival at 2 years

Estimated Enrollment:	44
Study Start Date:	November 2003
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077688

Locations


United States, Maryland
	University of Maryland Medical Center/Greenbaum Cancer Center
	Baltimore, Maryland, United States, 21201

United States, Ohio
	Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

United States, Washington
	University of Washington/Seattle Cancer Care Alliance
	Seattle, Washington, United States, 98109

Sponsors and Collaborators

Sonus Pharmaceuticals

More Information

Study ID Numbers:	SON-8184-1073
First Received:	February 10, 2004
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00077688
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urinary Bladder Diseases

Urinary Bladder Neoplasms

Ureteral Diseases

Urogenital Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Transitional cell carcinoma

Carcinoma

Urologic Diseases

Paclitaxel

Urethral Neoplasms

Ureteral Neoplasms

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Urethral Diseases

Antimitotic Agents

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Sonus Pharmaceuticals
Information provided by:	Sonus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00077688