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

This study has been completed.
Information provided by:
OncoGenex Technologies Identifier:
First received: February 10, 2004
Last updated: June 2, 2009
Last verified: June 2009
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by OncoGenex Technologies:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
OncoGenex Technologies
  More Information Identifier: NCT00077688     History of Changes
Other Study ID Numbers: SON-8184-1073 
Study First Received: February 10, 2004
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Ureteral Neoplasms
Urethral Neoplasms
Urinary Bladder Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ureteral Diseases
Urethral Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 23, 2016