Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002478
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer
Status:
TERMINATED
Status Verified Date:
2000-11
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of etoposide in treating patients who have refractory recurrent or metastatic ovarian or cervical cancer
PURPOSE Phase II trial to study the effectiveness of etoposide in treating patients who have refractory recurrent or metastatic ovarian or cervical cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of prolonged oral etoposide VP-16 in patients with advanced ovarian epithelial or cervical cancer II Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16
OUTLINE Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL If 4-6 responses are observed in the first 25 patients an additional 15 patients will be entered The estimated duration of the study is 8 months
OUTLINE Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL If 4-6 responses are observed in the first 25 patients an additional 15 patients will be entered The estimated duration of the study is 8 months
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-26LL | None | None | None |