Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031954
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2002-03-08
Brief Title:
Combination Chemotherapy in Treating Patients With Ovarian Epithelial Fallopian Tube or Peritoneal Cancer
Sponsor:
AGO Study Group
Organization:
AGO Study Group
Study Overview
Official Title:
A Phase II Study Of Paclitaxel Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
Status:
COMPLETED
Status Verified Date:
2015-12
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC stage IIB stage III or stage IV ovarian epithelial fallopian tube or peritoneal cancer that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC stage IIB stage III or stage IV ovarian epithelial fallopian tube or peritoneal cancer that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the tolerability and toxicity of paclitaxel carboplatin and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial fallopian tube or peritoneal carcinoma
Determine the response rate of patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the tolerability and toxicity of paclitaxel carboplatin and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial fallopian tube or peritoneal carcinoma
Determine the response rate of patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for 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 |
|---|---|---|---|
| EU-20146 | None | None | None |
| AGOSG-OVAR-8 | None | None | None |