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Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium Clinical research trials and Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium. Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium clinical trial. Subjects typically recieve the finest healthcare available for their Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium  Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
For Condition: Urologic Neoplasms
Status: Recruiting
Sponsor(s): Sonus Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
7 Clinical Sites *Recruiting*
3 Cities, ,
Russian Federation
Recruiting
Additional Information:
Study ID Numbers: SON-8184-1065;
Study Start Date: April 2002
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034177
Other Urologic Neoplasms Studies:
1. Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
2. Genetic Analysis of Inherited Urologic Malignant Disorders: Collection of Samples
3. A Phase 2 Trial of ALIMTA (pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
4. A Phase 2 Trial of ALIMTA (pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional cell Carcinoma of the Urothelium
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Safety and Efficacy of S-8184 in Second Line Treatment of Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
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