Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006903
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2000-12-06
Brief Title:
Fulvestrant in Treating Patients With Recurrent Persistent or Metastatic Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase II Study of Faslodex in RecurrentMetastatic Endometrial Carcinoma
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent persistent or metastatic endometrial cancer Estrogen can stimulate the growth of cancer cells Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Compare the probability of clinical response in estrogen receptor ER-positive vs ER-negative patients with recurrent persistent or metastatic endometrial cancer treated with fulvestrant
II Compare the relationship between response rate and intensity of receptor expression in patients treated with this drug
III Determine the frequency and intensity of toxicity of this drug in these patients
OUTLINE
Patients receive fulvestrant intramuscularly on day 1 Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Compare the probability of clinical response in estrogen receptor ER-positive vs ER-negative patients with recurrent persistent or metastatic endometrial cancer treated with fulvestrant
II Compare the relationship between response rate and intensity of receptor expression in patients treated with this drug
III Determine the frequency and intensity of toxicity of this drug in these patients
OUTLINE
Patients receive fulvestrant intramuscularly on day 1 Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00581 | REGISTRY | None | None |
| CDR0000068339 | None | None | None |
| GOG-0188 | OTHER | None | None |
| GOG-0188 | OTHER | None | None |
| U10CA180868 | NIH | None | None |