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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077688
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : June 4, 2009
Information provided by:
Achieve Life Sciences

Brief 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

Condition or disease Intervention/treatment Phase
Bladder Neoplasms Ureteral Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Drug: TOCOSOL Paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2003
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Time to treatment failure
  2. Time to progression
  3. Progression free survival
  4. Overall survival at 2 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077688

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
Achieve Life Sciences Identifier: NCT00077688     History of Changes
Other Study ID Numbers: SON-8184-1073
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Ureteral Neoplasms
Urethral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases
Urethral Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action