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TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium Clinical research trials and TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium. TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium
For Condition: Bladder Neoplasms,Carcinoma, Transitional Cell,Ureteral Neoplasms,Urethral Neoplasms
Status: Recruiting
Sponsor(s): Sonus Pharmaceuticals ,
Synopsis: 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
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 intitutional 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 NIC-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
Total Enrollment: 44
Location and Contact Information:
Swedish Cancer Institute *Recruiting*
Seattle, Washington, 98014
United States
Recruiting Toni Oien 206-386-2831
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Lisa Bearn 215-614-1811
Additional Information:
Study ID Numbers: SON-8184-1073;
Study Start Date: November 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077688
Other Urethral Neoplasms Studies:
1. TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium
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Other Urethral Neoplasms Clinical Trials
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TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium
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