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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Carcinoma, Transitional Cell

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Trial Information

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


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
- Total bilirubin
- SGOT & SGPT
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Authority:

United States: Food and Drug Administration

Study ID:

SON-8184-1073

NCT ID:

NCT00077688

Start Date:

November 2003

Completion Date:

September 2007

Related Keywords:

  • Bladder Neoplasms
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Ureteral Neoplasms
  • Urethral Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of Maryland Medical Center/Greenbaum Cancer CenterBaltimore, Maryland  21201
University of Washington/Seattle Cancer Care AllianceSeattle, Washington  98109