Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003865
Status:
WITHDRAWN
Last Update Posted:
2017-07-13
First Post:
1999-11-01
Brief Title:
Toremifene in Treating Patients With Ovarian Cancer
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary
Status:
WITHDRAWN
Status Verified Date:
2017-07
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 Estrogen can stimulate the growth of ovarian cancer cells Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen
PURPOSE Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer
PURPOSE Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer
Detailed Description:
OBJECTIVES
Determine the effects of toremifene in terms of response rate duration of response duration of survival and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary
Assess whether a dose response effect is likely for this regimen in these patients
Assess quality of life of these patients
OUTLINE This is a randomized study
Patients receive one of two doses of oral toremifene daily for 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before therapy and then every 4 weeks during therapy
Patients are followed every 12 weeks until death
PROJECTED ACCRUAL The study was closed before any patient accrual
Determine the effects of toremifene in terms of response rate duration of response duration of survival and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary
Assess whether a dose response effect is likely for this regimen in these patients
Assess quality of life of these patients
OUTLINE This is a randomized study
Patients receive one of two doses of oral toremifene daily for 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before therapy and then every 4 weeks during therapy
Patients are followed every 12 weeks until death
PROJECTED ACCRUAL The study was closed before any patient accrual
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V99-1540 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067029 | REGISTRY | None | None |