Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191100

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Cervical Cancer Radiation Therapy

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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
1: Experimental 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 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
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

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 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

2: Active Comparator

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

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:

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

No publications provided

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

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Genital Neoplasms, Female
Adjuvants, Immunologic
Uterine Diseases
Urogenital Neoplasms
Immunosuppressive Agents

Antiviral Agents
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Cisplatin
Radiation-Sensitizing Agents
Uterine Neoplasms
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Uterine Cervical Neoplasms
Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Uterine Neoplasms
Gemcitabine

ClinicalTrials.gov processed this record on September 02, 2009