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

Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Urologic Neoplasms

Carcinoma, Transitional Cell

Eligibility:

All Genders

20-74 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

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

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)

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

End Date :

September 1 2006

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00191971

Start Date

January 1 2004

End Date

September 1 2006

Last Update

November 6 2007

Active Locations (12)

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Page 1 of 3 (12 locations)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Fukuoka, Japan

Hokkaido, Japan

Ibaraki, Japan

Kagoshima, Japan

Trial Details

Trial ID

NCT00191971

Start Date

January 1 2004

End Date

September 1 2006

Last Update

November 6 2007

Status: