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

Purpose

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

Condition	Intervention	Phase
Urologic Neoplasms Carcinoma, Transitional Cell	Drug: Gemcitabine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Response rate

Secondary Outcome Measures:

Progression-free survival
Overall survival

Estimated Enrollment:	40
Study Start Date:	January 2004
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191971

Locations

Japan
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
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
Hokkaido, Japan
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
Ibaragi, Japan
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
Iwate, Japan
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
Kagoshima, Japan
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
Kyoto, Japan
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
Miyagi, Japan
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
Nagasaki, Japan
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
Okayama, Japan
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
Osaka, Japan
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
Shizuoka, Japan
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
Tokyo, Japan

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00191971 History of Changes
Other Study ID Numbers:	7994, B9E-JE-BL21
Study First Received:	September 12, 2005
Last Updated:	November 5, 2007
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eli Lilly and Company:

Transitional cell carcinoma of urothelium

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urogenital Neoplasms
Neoplasms by Site
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013