Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004921
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2000-03-07
Brief Title:
High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
Sponsor:
EBMT Solid Tumors Working Party
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2002-07
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 It is not yet known which chemotherapy regimen is most effective for ovarian epithelial cancer
PURPOSE This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery
PURPOSE This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery
Detailed Description:
OBJECTIVES
Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy
Compare the overall survival toxicity and quality of life in this patient population receiving these two treatment regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive 5 courses of sequential high-dose chemotherapy as follows
Courses 1 and 2 Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell PBSC collection Patients receive filgrastim G-CSF subcutaneously SC beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached
Courses 3 and 4 Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1 At 72 hours following completion of carboplatin patients receive PBSC infusion Beginning one day following PBSC infusion patients receive G-CSF SC until blood counts recover
Course 5 Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3 Patients receive PBSC and G-CSF as in courses 3 and 4
Treatment repeats every 3-4 weeks
Arm II Patients receive standard chemotherapy consisting of carboplatin or cisplatin and paclitaxel IV over 3 hours every 3 weeks for 6 courses Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks
Quality of life is assessed prior to therapy at 4-6 weeks following completion of therapy and then at 3 months 9 months and 15 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 208 patients 104 per treatment arm will be accrued for this study
Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy
Compare the overall survival toxicity and quality of life in this patient population receiving these two treatment regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive 5 courses of sequential high-dose chemotherapy as follows
Courses 1 and 2 Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell PBSC collection Patients receive filgrastim G-CSF subcutaneously SC beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached
Courses 3 and 4 Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1 At 72 hours following completion of carboplatin patients receive PBSC infusion Beginning one day following PBSC infusion patients receive G-CSF SC until blood counts recover
Course 5 Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3 Patients receive PBSC and G-CSF as in courses 3 and 4
Treatment repeats every 3-4 weeks
Arm II Patients receive standard chemotherapy consisting of carboplatin or cisplatin and paclitaxel IV over 3 hours every 3 weeks for 6 courses Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks
Quality of life is assessed prior to therapy at 4-6 weeks following completion of therapy and then at 3 months 9 months and 15 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 208 patients 104 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99040 | None | None | None |
| EBMT-HIDOC-EIS | None | None | None |
| EBMT-OVCAT | None | None | None |