| September 12, 2005 |
| August 8, 2009 |
| May 2002 |
| April 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| Overall survival - the expected median overall survival for the experimental arm is 78.6 months. |
| Complete list of historical versions of study NCT00191100 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Time to progressive disease
- Local failure rate.
- Tumor response rate.
- Toxicity.
- - all performed at time of analysis for primary endpoint
|
| |
| Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix |
| 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 |
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 III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Cancer of Cervix |
- Drug: Gemcitabine
- Drug: Cisplatin
- Radiation: Brachytherapy
- Radiation: Pelvic radiation
|
- 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
- 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
|
| |
| |
| Completed |
| 515 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Bosnia and Herzegovina, India, Mexico, Pakistan, Peru, Thailand |
| |
| NCT00191100 |
| Chief Medical Officer, Eli Lilly |
| 4015, B9E-MC-JHQS |
| Eli Lilly and Company |
|
| 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 |
|
|
| Eli Lilly and Company |
| August 2009 |