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Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
Urologic Neoplasms

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Trial Information

Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium


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.


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

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; time to disease progression; duration of response; survival; toxicities

Outcome Time Frame:

After all patients completed treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SON-8184-1065

NCT ID:

NCT00034177

Start Date:

April 2002

Completion Date:

September 2007

Related Keywords:

  • Urologic Neoplasms
  • Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
  • Neoplasms
  • Carcinoma, Transitional Cell
  • Urologic Neoplasms

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