Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068549
Status:
COMPLETED
Last Update Posted:
2014-12-25
First Post:
2003-09-10
Brief Title:
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma Stages I-IV Limited to the Pelvis
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis
II Determine the maximum tolerated dose MTD of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen
II Determine the site of recurrence local versus distant in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of gemcitabine
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 15 22 29 and 36 in the absence of disease progression or unacceptable toxicity Patients also undergo external whole pelvis radiotherapy once daily on days 1-5 8-13 15-20 22-27 and 29-34 After completion of external beam radiotherapy patients undergo intracavitary radiotherapy and parametrial radiotherapy The total elapsed time for completion of all radiotherapy is not more than 8 weeks
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
I Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis
II Determine the maximum tolerated dose MTD of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen
II Determine the site of recurrence local versus distant in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of gemcitabine
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 15 22 29 and 36 in the absence of disease progression or unacceptable toxicity Patients also undergo external whole pelvis radiotherapy once daily on days 1-5 8-13 15-20 22-27 and 29-34 After completion of external beam radiotherapy patients undergo intracavitary radiotherapy and parametrial radiotherapy The total elapsed time for completion of all radiotherapy is not more than 8 weeks
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| CDR0000327715 | None | None | None |
| GOG-9912 | OTHER | None | None |
| NCI-2012-02553 | REGISTRY | None | None |
| GOG-9912 | OTHER | None | None |