Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003560
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
Status:
UNKNOWN
Status Verified Date:
2003-09
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 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 combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer fallopian tube cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Evaluate the response rate duration of response and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma fallopian tube carcinoma papillary serous cancer of the uterus or primary peritoneal carcinoma treated with docetaxel and carboplatin
Evaluate the feasibility and toxicity of this regimen in these patients
Evaluate the effect of this regimen on quality of life of these patients
OUTLINE This is an open-label study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy
PROJECTED ACCRUAL Approximately 14-40 patients will be accrued for this study within 25 years
Evaluate the response rate duration of response and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma fallopian tube carcinoma papillary serous cancer of the uterus or primary peritoneal carcinoma treated with docetaxel and carboplatin
Evaluate the feasibility and toxicity of this regimen in these patients
Evaluate the effect of this regimen on quality of life of these patients
OUTLINE This is an open-label study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy
PROJECTED ACCRUAL Approximately 14-40 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| NCI-V98-1467 | None | None | None |
| CPMC-IRB-8437 | None | None | None |