Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002595
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Toremifene in Treating Patients With Desmoid Tumors
Sponsor:
Advocate Lutheran General Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS
Status:
COMPLETED
Status Verified Date:
2010-08
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 cancer cells Hormone therapy using toremifene may fight the growth of desmoid tumors by reducing the production of estrogen
PURPOSE Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors
PURPOSE Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors
Detailed Description:
OBJECTIVES I Determine the efficacy of toremifene in terms of tumor response rate and symptom relief in patients with desmoid tumors II Determine the safety of this regimen in these patients III Determine the quality of life of patients treated with this regimen
OUTLINE Patients are stratified by gender Patients receive oral toremifene daily until complete or maximal response in the absence of disease progression or unacceptable toxicity Patients achieving maximal response undergo complete resection of all lesions if feasible Nonsurgical candidates with severe or life-threatening disease not achieving partial or complete response or symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson Patients with stable disease who do not undergo surgery may continue on toremifene for a maximum of 12 months at the discretion of the treating physician Patients who continue to experience symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson Quality of life is assessed at baseline and at 2 and 6 months Patients are followed every 8 weeks for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-72 12-36 per stratum will be accrued for this study
OUTLINE Patients are stratified by gender Patients receive oral toremifene daily until complete or maximal response in the absence of disease progression or unacceptable toxicity Patients achieving maximal response undergo complete resection of all lesions if feasible Nonsurgical candidates with severe or life-threatening disease not achieving partial or complete response or symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson Patients with stable disease who do not undergo surgery may continue on toremifene for a maximum of 12 months at the discretion of the treating physician Patients who continue to experience symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson Quality of life is assessed at baseline and at 2 and 6 months Patients are followed every 8 weeks for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-72 12-36 per stratum 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 |
|---|---|---|---|
| NCI-V91-0211 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063797 | REGISTRY | None | None |