Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002562
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Advanced Refractory or Recurrent Cervical or Vaginal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
EVALUATION OF PACLITAXEL TAXOL IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA
Status:
COMPLETED
Status Verified Date:
2005-12
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
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced refractory or recurrent cervical or vaginal cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced refractory or recurrent cervical or vaginal cancer
Detailed Description:
OBJECTIVES I Estimate the frequency and duration of objective response duration of progression-free interval and survival of patients treated with paclitaxel for advanced persistent or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols II Determine the frequency and severity of observed adverse effects on this study
OUTLINE Single-Agent Chemotherapy Paclitaxel TAX NSC-673089
PROJECTED ACCRUAL 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum If more than 3 patients in a given stratum respond an additional 25 patients will be accrued to that stratum As of 0795 the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix
OUTLINE Single-Agent Chemotherapy Paclitaxel TAX NSC-673089
PROJECTED ACCRUAL 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum If more than 3 patients in a given stratum respond an additional 25 patients will be accrued to that stratum As of 0795 the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix
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 |
|---|---|---|---|
| GOG-128B | None | None | None |