Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003382
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of GemcitabineTopotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
Status:
TERMINATED
Status Verified Date:
2006-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim G-CSF in patients with refractory ovarian or fallopian tube cancer
Describe and quantitate the clinical toxicities of these regimens in this patient population
OUTLINE This is a dose escalation study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4 Some patients receive filgrastim G-CSF subcutaneously on days 9-14 Treatment repeats every 28 days for up to 5-10 courses
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity DLT Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience DLT
Patients are followed every 2-3 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study
Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim G-CSF in patients with refractory ovarian or fallopian tube cancer
Describe and quantitate the clinical toxicities of these regimens in this patient population
OUTLINE This is a dose escalation study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4 Some patients receive filgrastim G-CSF subcutaneously on days 9-14 Treatment repeats every 28 days for up to 5-10 courses
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity DLT Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience DLT
Patients are followed every 2-3 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study
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-9702 | None | None | None |