Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003297
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Phase III Study of High Dose Topotecan Mitoxantrone and Thiotepa TMT Followed by Autologous Stem Cell Transplant in Patients With Recurrent Platinum Resistant Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2000-09
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian cancer that has not recurred or that has not responded to previous chemotherapy
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian cancer that has not recurred or that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and the dose limiting toxicities of topotecan mitoxantrone and thiotepa given in combination followed by autologous peripheral blood stem cell transplantation in patients with recurrent or refractory platinum resistant epithelial ovarian cancer II Determine the progression-free survival and overall survival of these patients after this therapy
OUTLINE This is a dose escalation study of topotecan All patients have peripheral stem cells collected Patients then receive topotecan according to an escalating dose schedule and mitoxantrone and thiotepa on a fixed dose schedule Patients receive topotecan by continuous infusion for 24 hours on days 1-3 mitoxantrone intravenously over 1 hour on days 1-3 and thiotepa intravenously over 4 hours on days 1-3 followed 48 hours later by infusion of their peripheral stem cells Patients may receive a second course of chemotherapy and peripheral stem cell transplantation in the absence of disease progression and unacceptable toxicity Dose escalation of topotecan continues in cohorts of 3-6 patients each until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity Patients are followed every week for the first month then every month for 6 months every 3 months for 1 year and then every 6 months
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study
OUTLINE This is a dose escalation study of topotecan All patients have peripheral stem cells collected Patients then receive topotecan according to an escalating dose schedule and mitoxantrone and thiotepa on a fixed dose schedule Patients receive topotecan by continuous infusion for 24 hours on days 1-3 mitoxantrone intravenously over 1 hour on days 1-3 and thiotepa intravenously over 4 hours on days 1-3 followed 48 hours later by infusion of their peripheral stem cells Patients may receive a second course of chemotherapy and peripheral stem cell transplantation in the absence of disease progression and unacceptable toxicity Dose escalation of topotecan continues in cohorts of 3-6 patients each until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity Patients are followed every week for the first month then every month for 6 months every 3 months for 1 year and then every 6 months
PROJECTED ACCRUAL A total of 21-50 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 |
|---|---|---|---|
| P30CA051008 | NIH | None | None |
| GUMC-97342 | None | None | None |
| NCI-G98-1414 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |