2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen

A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191971

Enrollment

Registered

2005-09-19

Start date

2004-01-31

Completion date

2006-09-30

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Transitional Cell, Urologic Neoplasms

Keywords

Transitional cell carcinoma of urothelium

Brief summary

To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium

Interventions

DRUGGemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Histologically and/or cytologically confirmed TCC * Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP regimen * To have at least one measurable region * PS: 0-2 * To have adequate organ function (bone marrow, liver and renal function)

Exclusion criteria

* To have Interstitial pneumonia or pulmonary fibrosis * Within 4 weeks after the latest chemotherapy or radiotherapy * To have brain metastasis with symptom * To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival	—
Overall survival	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026