Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006089
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2000-08-03
Brief Title:
Trastuzumab in Treating Patients With Stage III Stage IV or Recurrent Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Trastuzumab MoAb HER2 in Patients With Advanced Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III stage IV or recurrent endometrial cancer
Detailed Description:
PRIMARY OOBJECTIVES
I Determine the antitumor activity of trastuzumab Herceptin in terms of response in patients with advanced recurrent or persistent endometrial adenocarcinoma that demonstrates HER2neu gene amplification by fluorescent in situ hybridization
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with this regimen
II Determine the effects of prognostic factors ie initial performance status and histological grade in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-42 patients will be accrued for this study within 12 years
I Determine the antitumor activity of trastuzumab Herceptin in terms of response in patients with advanced recurrent or persistent endometrial adenocarcinoma that demonstrates HER2neu gene amplification by fluorescent in situ hybridization
II Determine the toxicity of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with this regimen
II Determine the effects of prognostic factors ie initial performance status and histological grade in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 25-42 patients will be accrued for this study within 12 years
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-2012-02356 | REGISTRY | None | None |
| CDR0000068091 | None | None | None |
| GOG-0181B | None | None | None |
| GOG-0181-B | OTHER | None | None |
| GOG-0181B | OTHER | None | None |