Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005612
Status:
TERMINATED
Last Update Posted:
2012-09-26
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III Study of Intensive-Dose Etoposide Topotecan and Carboplatin ETC Followed by Autologous Stem Cell Rescue in Chemosensitive Ovarian Cancer Patients With Either Minimal Residual Disease or at First Relapse
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETC
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 autologous 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 followed by peripheral stem cell transplantation in treating patients who have ovarian epithelial cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine the toxicity and potential efficacy of high dose chemotherapy HDC comprised of etoposide topotecan and carboplatin ETC followed by autologous stem cell transplantation in patients with ovarian epithelial cancer II Determine the maximum tolerated dose of topotecan when combined with etoposide and carboplatin in these patients III Determine the disease free survival DFS and overall survival OS in patients treated with this regimen IV Measure the amount and subcellular location of DNA topoisomerase I and II- alpha in ovarian cancer biopsies before HDC and at relapse to determine the role of alterations of topoisomerases in the drug resistance of ovarian cancer V Correlate the amount and location of both enzymes before HDC with clinical outcome DFS and OS and plasma concentrations of topotecan and carboplatin in these patients VI Correlate the levels of signal transducers and activators of transcription STAT and expression of bcl-2 family proteins with response to chemotherapy and clinical outcome DFS and OS in these patients VII Measure the levels of STAT and determine the expression of bcl-2 family proteins in tumor biopsies before HDC and at relapse to determine the role of these cellular pathways in drug response VIII Determine the pharmacokinetic and pharmacodynamic relationship of high dose topotecan combined with carboplatin in these patients
OUTLINE This is a dose escalation study of topotecan Mobilization After completion of salvage chemotherapy and within 6 weeks of second look laparotomy patients receive cyclophosphamide IV over 2 hours and paclitaxel IV over 2 hours for 2 days Patients then receive filgrastim G-CSF subcutaneously daily beginning 24 hours after completion of chemotherapy and continuing until autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells High dose chemotherapy After priming chemotherapy and within 6 weeks of second look laparotomy patients receive carboplatin IV over 1 hour on days -8 to -6 topotecan IV over 30 minutes on days -7 to -5 beginning 12 hours after completion of carboplatin infusion and etoposide IV over 4 hours on days -5 to -3 beginning 12 hours after completion of the last topotecan infusion Cohorts of 4-12 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 6 or more of 12 patients experience dose limiting toxicity Transplantation PBSC are reinfused on day 0 Patients are followed at 3 and 6 months then annually thereafter
PROJECTED ACCRUAL Approximately 4-30 patients will be accrued for this study within 3-4 years
OUTLINE This is a dose escalation study of topotecan Mobilization After completion of salvage chemotherapy and within 6 weeks of second look laparotomy patients receive cyclophosphamide IV over 2 hours and paclitaxel IV over 2 hours for 2 days Patients then receive filgrastim G-CSF subcutaneously daily beginning 24 hours after completion of chemotherapy and continuing until autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells High dose chemotherapy After priming chemotherapy and within 6 weeks of second look laparotomy patients receive carboplatin IV over 1 hour on days -8 to -6 topotecan IV over 30 minutes on days -7 to -5 beginning 12 hours after completion of carboplatin infusion and etoposide IV over 4 hours on days -5 to -3 beginning 12 hours after completion of the last topotecan infusion Cohorts of 4-12 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 6 or more of 12 patients experience dose limiting toxicity Transplantation PBSC are reinfused on day 0 Patients are followed at 3 and 6 months then annually thereafter
PROJECTED ACCRUAL Approximately 4-30 patients will be accrued for this study within 3-4 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 |
|---|---|---|---|
| NCI-G00-1745 | OTHER_GRANT | NCI | None |
| MCC-IRB-5418 | OTHER | None | None |