Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258362
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-11-22
Brief Title:
Carboplatin Docetaxel and Radiation Therapy in Treating Patients With Stage IIIIV or Recurrent Endometrial Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III IV and Recurrent Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2017-12
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:
RATIONALE Drugs used in chemotherapy such as carboplatin and docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III stage IV or recurrent endometrial cancer
PURPOSE This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III stage IV or recurrent endometrial cancer
Detailed Description:
OBJECTIVES
Primary
Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel
Secondary
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE Patients receive docetaxel intravenous IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 3 courses After hematologic recovery from chemotherapy patients receive radiotherapy 5 days a week for up to 7 weeks Beginning 3-4 weeks later patients receive another 3 courses of docetaxel and carboplatin
After completion of study treatment patients are followed periodically for 2 years
Primary
Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel
Secondary
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE Patients receive docetaxel intravenous IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 3 courses After hematologic recovery from chemotherapy patients receive radiotherapy 5 days a week for up to 7 weeks Beginning 3-4 weeks later patients receive another 3 courses of docetaxel and carboplatin
After completion of study treatment patients are followed periodically for 2 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 |
|---|---|---|---|
| UMN-WCC-38 | OTHER | None | None |
| 13062 | OTHER | Sanofi-Aventis Pharmaceuticals | None |