Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075543
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2004-01-09
Brief Title:
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer
Determine the toxicity of this regimen in these patients
Secondary
Determine the tolerance profile of patients treated with this regimen
Determine a recommended phase III dose of this regimen in these patients
Determine the efficacy of this regimen in terms of objective response rate and radiological and biological response rate CA 125 in these patients
Determine the complete pathological response in patients treated with this regimen as first-line therapy
Determine the duration of the objective response in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 30-39 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer
Determine the toxicity of this regimen in these patients
Secondary
Determine the tolerance profile of patients treated with this regimen
Determine a recommended phase III dose of this regimen in these patients
Determine the efficacy of this regimen in terms of objective response rate and radiological and biological response rate CA 125 in these patients
Determine the complete pathological response in patients treated with this regimen as first-line therapy
Determine the duration of the objective response in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 30-39 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20332 | None | None | None |
| FRE-GERCOR-DOCELOXO-01-1 | None | None | None |