Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005840
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
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 combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells
Detailed Description:
OBJECTIVES
I Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer
II Assess the time to disease progression and overall survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of paclitaxel and cisplatin
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1 8 15 22 29 and 36 Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study
I Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer
II Assess the time to disease progression and overall survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of paclitaxel and cisplatin
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1 8 15 22 29 and 36 Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study
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 |
| NCI-2012-02334 | REGISTRY | None | None |
| CDR0000067856 | None | None | None |
| GOG-9907 | OTHER | None | None |
| GOG-9907 | OTHER | None | None |