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Phase II Study of Genexol-PM, a Cremophor-free, Polymeric Micelle Formulation of Paclitaxel for Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Ureter Cancer

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Trial Information

Phase II Study of Genexol-PM, a Cremophor-free, Polymeric Micelle Formulation of Paclitaxel for Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum


Inclusion Criteria:



1. Histologically confirmed TCC of the urothelial tract (bladder, renal pelvis, or
ureter)

2. Prior exposure to gemcitabine-platinum regimen as either adjuvant or palliative
chemotherapy.

3. Unidimensionally measurable disease outside prior radiotherapy ports

4. Age 18 years or older

5. ECOG performance status of 0~2

6. Life expectancy of at least 3 months

7. Adequate BM function (ANC >1,500/mm3 & Platelet >100,000/mm3)

8. Adequate hepatic function (Bilirubin no greater than 2 times upper limit of normal
(ULN) & AST or ALT no greater than 2.5 times ULN), and renal function (creatinine
<1.5 X times ULN)

9. No pre-existing clinically significant grade 2 or greater neuropathy

Exclusion Criteria:

1. Pregnant or lactating patients

2. Presence or history of CNS metastasis

3. Patients with prior RT to the axial skeleton within 4 weeks of chemotherapy start to
greater than 25% of bone marrow

4. Any preexisting medical condition of sufficient severity to prevent full compliance
with the study, including active infection, active cardiac symptoms

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:

Response rate

Outcome Description:

Objective tumor response rate according to RECIST criteria V.1.0

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jae-Lyun Lee, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

UOSG-AMC-0702

NCT ID:

NCT01426126

Start Date:

December 2007

Completion Date:

August 2011

Related Keywords:

  • Bladder Cancer
  • Ureter Cancer
  • urothelial carcinoma
  • gemcitabine
  • platinum
  • refractory
  • salvage chemotherapy
  • Urinary Bladder Neoplasms
  • Ureteral Neoplasms

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