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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191100
First received: September 12, 2005
Last updated: August 8, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Cancer of Cervix
Drug: Gemcitabine
Drug: Cisplatin
Radiation: Brachytherapy
Radiation: Pelvic radiation
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Local Failure Rate [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Tumor Response [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Number of Participants Who Died From Any Cause at Various Time Points [ Time Frame: baseline to date of death from any cause (includes 60 month follow-up period) ] [ Designated as safety issue: No ]
  • Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 515
Study Start Date: May 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks

Brachytherapy, 30-35 Gy over 1 week

Two week rest period with no chemotherapy or radiation

Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles

Drug: Gemcitabine
Other Names:
  • LY188011
  • Gemzar
Drug: Cisplatin Radiation: Brachytherapy
Brachytherapy, 30-35 Gy over 1 week
Radiation: Pelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Active Comparator: 2

Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks

Brachytherapy, 30-35 Gy over 1 week

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191100

Locations
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, Argentina
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, Bosnia and Herzegovina
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, India
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, Mexico
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, Pakistan
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, Peru
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, Thailand
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:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191100     History of Changes
Other Study ID Numbers: 4015, B9E-MC-JHQS
Study First Received: September 12, 2005
Results First Received: March 30, 2009
Last Updated: August 8, 2009
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014