Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium

This study has been completed.
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034177
First received: April 23, 2002
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.


Condition Intervention Phase
Urologic Neoplasms
Drug: S-8184 Paclitaxel Injectable Emulsion
Drug: Experimental Arm: 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: 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

Resource links provided by NLM:


Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:
  • Objective response rate; time to disease progression; duration of response; survival; toxicities [ Time Frame: After all patients completed treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine time to disease progression [ Time Frame: After all patients have completed treatment ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: S-8184 Paclitaxel Injectable Emulsion Drug: Experimental Arm: TOCOSOL Paclitaxel
    Doses of 80, 100 and 120mg/m2
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Monica Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034177     History of Changes
Other Study ID Numbers: SON-8184-1065
Study First Received: April 23, 2002
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoGenex Pharmaceuticals:
Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urogenital Neoplasms
Neoplasms by Site
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014