Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027690
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2001-12-07
Brief Title:
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of ZD 1839 IRESSA NSC 715055 in the Treatment of Persistent or Recurrent Endometrial Carcinoma
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:
Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer
Detailed Description:
OBJECTIVES
I Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib
II Determine the nature and degree of toxicity of this drug in these patients III Determine the progression-free and overall survival of patients treated with this drug
IV Determine the effects of this drug on the levels of epidermal growth factor receptors EGFR c-ErbB2 HER-2neu receptors estrogen receptors ER and progesterone receptors PR both PR and PRB in tumor specimens of these patients
V Determine if an association exists between the levels of EGFR ER PR PRB and HER-2neu serum concentrations of gefitinib gefitinib activity and soluble EGFR and clinical outcome in patients treated with this drug
VI Determine the frequency of clinical response partial and complete response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 25-6 years
I Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib
II Determine the nature and degree of toxicity of this drug in these patients III Determine the progression-free and overall survival of patients treated with this drug
IV Determine the effects of this drug on the levels of epidermal growth factor receptors EGFR c-ErbB2 HER-2neu receptors estrogen receptors ER and progesterone receptors PR both PR and PRB in tumor specimens of these patients
V Determine if an association exists between the levels of EGFR ER PR PRB and HER-2neu serum concentrations of gefitinib gefitinib activity and soluble EGFR and clinical outcome in patients treated with this drug
VI Determine the frequency of clinical response partial and complete response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 25-6 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-2012-02429 | REGISTRY | None | None |
| CDR0000069057 | None | None | None |
| GOG-0229C | OTHER | None | None |
| GOG-0229C | OTHER | None | None |