Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217568
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-09-20
Brief Title:
Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-09
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 docetaxel and carboplatin 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
PURPOSE This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer
PURPOSE This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse
Determine the response rates complete and partial response in patients treated with this regimen
Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 21 days for up to 6 courses
After completion of study treatment patients are followed at 3 weeks every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4-5 years
Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse
Determine the response rates complete and partial response in patients treated with this regimen
Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 21 days for up to 6 courses
After completion of study treatment patients are followed at 3 weeks every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| CDR0000441307 | REGISTRY | PDQ | None |
| PSOC-1702 | None | None | None |
| AVENTIS-PSOC-1702 | None | None | None |
| PSOC-IRB-4861 | None | None | None |