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OpenTrials
Completed

NCT Number: NCT00191971

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

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

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Key information

Conditions

Urologic Neoplasms Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gemcitabine

Drug

Primary outcomes

  1. Response rate

Secondary outcomes

  1. Progression-free survival

  2. Overall survival

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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