Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023699
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-09-13
Brief Title:
Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of ZD1839 Iressa NSC 715055 in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2003-08
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 Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the antitumor cytostatic activity of gefitinib in terms of 6-month progression-free survival in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
Determine the nature and degree of toxicity in patients treated with this drug
Determine the partial and complete response rates in patients treated with this drug
Determine the duration of progression-free and overall survival in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily 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 Approximately 22-60 patients will be accrued for this study within 1-2 years
Determine the antitumor cytostatic activity of gefitinib in terms of 6-month progression-free survival in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
Determine the nature and degree of toxicity in patients treated with this drug
Determine the partial and complete response rates in patients treated with this drug
Determine the duration of progression-free and overall survival in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily 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 Approximately 22-60 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| GOG-0170C | None | None | None |