Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 5:52 PM
Study NCT ID:
NCT00004060
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced Ovarian, Tubal, or Peritoneal Cancer Refractory to Platinum, Taxane and Topotecan
Status:
COMPLETED
Status Verified Date:
2012-05
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 DX-8951f in treating patients who have recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.
Detailed Description:
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent, metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients.
OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 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?: