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

Cancer of Cervix Clinical Trial

Official title:

Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191100
• Other study ID #: 4015
• Secondary ID: B9E-MC-JHQS
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: August 8, 2009
• Start date: May 2002
• Est. completion date: April 2008

Study information

• Verified date: August 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Cervix
• Uterine Cervical Neoplasms

Intervention

Drug:
• Gemcitabine

• Cisplatin

Radiation:
• Brachytherapy
Brachytherapy, 30-35 Gy over 1 week
• Pelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks

Locations

Country	Name	City	State
Argentina	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
Bosnia and Herzegovina	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
India	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
Mexico	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
Pakistan	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.	Karachi
Peru	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.	Lima
Thailand	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.	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Bosnia and Herzegovina,  India,  Mexico,  Pakistan,  Peru,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years		Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively	No
Secondary	Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points		Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively	No
Secondary	Local Failure Rate		Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively	No
Secondary	Tumor Response		Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively	No
Secondary	Number of Participants Who Died From Any Cause at Various Time Points		baseline to date of death from any cause (includes 60 month follow-up period)	No
Secondary	Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points		Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively	No

External Links

•   Lilly Clinical Trial Registry