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

Phase 2CompletedNCT00191971

Eli Lilly and Company40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urologic Neoplasms Carcinoma, Transitional Cell

Interventions

GemcitabineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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)

Locations (12)

Outcomes

Primary Outcomes

Response rate

Secondary Outcomes

Progression-free survival

Overall survival

Data from ClinicalTrials.gov

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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

Kyoto, Japan

Miyagi, Japan

Nagasaki, Japan

Numakunai, Japan

Okayama, Japan

Osaka, Japan

...and 2 more locations