Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012090
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-03-03
Brief Title:
Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary Fallopian Tube or Peritoneum
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial Of Oral Bicalutamide With Subcutaneous Goserelin In Patients With Epithelial Ovarian Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission
Status:
COMPLETED
Status Verified Date:
2013-06
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 Some tumors need growth factors produced by the bodys white blood cells to keep growing Goserelin may interfere with the growth factor and may stop the tumor from growing Bicalutamide may prevent androgens from stimulating the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating patients who have refractory or recurrent cancer of the ovary fallopian tube or peritoneum
PURPOSE Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating patients who have refractory or recurrent cancer of the ovary fallopian tube or peritoneum
Detailed Description:
OBJECTIVES I Determine the time-to-treatment failure in patients with ovarian epithelial fallopian tube or peritoneal carcinoma in second or greater remission treated with bicalutamide and goserelin II Assess luteinizing hormone and follicle-stimulating hormone suppression in correlation with serum vascular endothelial growth factor levels and determine if these levels are related to time to treatment failure in these patients III Correlate the presence or absence of androgen receptor tissue expression by immunohistochemistry and androgen receptor gene trinucleotide repeat length to time to treatment failure in these patients
OUTLINE Patients receive oral bicalutamide once daily and goserelin subcutaneously once every 4 weeks Treatment continues in the absence of unacceptable toxicity until disease recurrence
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
OUTLINE Patients receive oral bicalutamide once daily and goserelin subcutaneously once every 4 weeks Treatment continues in the absence of unacceptable toxicity until disease recurrence
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| NCI-G01-1918 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068483 | REGISTRY | None | None |