Status:

COMPLETED

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

Lead Sponsor:

Eli Lilly and Company

Conditions:

Cancer of Cervix

Eligibility:

FEMALE

18-70 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy,...

Eligibility Criteria

Inclusion

  • diagnosed with cancer of cervix
  • tumor that can be measured
  • no previous treatment with chemotherapy or radiation for this cancer
  • Karnofsky Performance Status Score \>=70
  • able to give written consent
  • willing and able to participate in the study, both during the active treatment and the follow-up period.

Exclusion

  • impairment such as hearing loss from prior cisplatin therapy
  • damage to nerves such as being unable to distinguish hot and cold to touch
  • used other experimental medication in past 30 days
  • lab test results are not within the limits required for this study
  • pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.

Key Trial Info

Start Date :

May 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

515 Patients enrolled

Trial Details

Trial ID

NCT00191100

Start Date

May 1 2002

End Date

April 1 2008

Last Update

August 11 2009

Active Locations (7)

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Page 1 of 2 (7 locations)

1

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.

Buenos Aires, Argentina

2

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.

Sarajevo, Bosnia and Herzegovina

3

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.

Mumbai, India

4

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.

Mexico City, Mexico