Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003064
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent Refractory or Recurrent Advanced Stage III or IV Epithelial Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer fallopian tube or primary peritoneal cancer
PURPOSE Phase III trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide phosphate as a component of a multicourse high dose chemotherapy regimen supported by peripheral blood stem cell transplantation in patients with persistent or recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
Evaluate the response time to progression disease free survival and overall survival in this patient population
OUTLINE This is a dose escalation study of topotecan
All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy Subcutaneous filgrastim G-CSF is given beginning 24 hours after induction dose Following induction therapy peripheral blood stem cells PBSC are harvested After patients receive high dose paclitaxel and carboplatin chemotherapy a portion of the PBSC are reinfused When patients recover from the paclitaxelcarboplatin chemotherapy the administration of topotecan and etoposide phosphate begins Topotecan is administered as a 72 hour continuous infusion according to a dose escalation schedule with a fixed dose of etoposide phosphate A second portion of PBSC are reinfused after topotecanetoposide phosphate chemotherapy A course of thiotepa is given along with the final portion of PBSC after treatment with topotecan and etoposide phosphate
Dose escalation of topotecan continues 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 3 months for 1 year and every 4 months thereafter to determine progression free and overall survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for the phase I portion of this study and 25 more patients will be accrued for the phase II portion
Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide phosphate as a component of a multicourse high dose chemotherapy regimen supported by peripheral blood stem cell transplantation in patients with persistent or recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
Evaluate the response time to progression disease free survival and overall survival in this patient population
OUTLINE This is a dose escalation study of topotecan
All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy Subcutaneous filgrastim G-CSF is given beginning 24 hours after induction dose Following induction therapy peripheral blood stem cells PBSC are harvested After patients receive high dose paclitaxel and carboplatin chemotherapy a portion of the PBSC are reinfused When patients recover from the paclitaxelcarboplatin chemotherapy the administration of topotecan and etoposide phosphate begins Topotecan is administered as a 72 hour continuous infusion according to a dose escalation schedule with a fixed dose of etoposide phosphate A second portion of PBSC are reinfused after topotecanetoposide phosphate chemotherapy A course of thiotepa is given along with the final portion of PBSC after treatment with topotecan and etoposide phosphate
Dose escalation of topotecan continues 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 3 months for 1 year and every 4 months thereafter to determine progression free and overall survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for the phase I portion of this study and 25 more patients will be accrued for the phase II portion
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 |
|---|---|---|---|
| NCI-G97-1327 | None | None | None |
| CPMC-IRB-7866 | None | None | None |