Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004060
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
1999-12-10
Brief Title:
Chemotherapy in Treating Patients With Recurrent Metastatic or Unresectable Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
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:
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 |
|---|---|---|---|
| MDA-DM-98265 | None | None | None |
| DAIICHI-8951A-PRT008 | None | None | None |