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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

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, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.