Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004221
Status:
TERMINATED
Last Update Posted:
2017-08-09
First Post:
2000-01-28
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin Paclitaxel and Topotecan With Peripheral Blood Stem Cell PBSC Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2017-08
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:
Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer 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
Detailed Description:
OBJECTIVES
I Determine the safety and feasibility of multiple courses of high dose carboplatin paclitaxel and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma
II Determine the pathological complete response rate disease free survival and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Mobilization and harvest Within 8 weeks of surgical debulking patients receive cyclophosphamide IV over 1 hour followed 4 hours later by paclitaxel IV over 24 hours Patients receive filgrastim G-CSF subcutaneously SQ daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells
High dose chemotherapy and transplantation 3 weeks after PBSC harvest Patients receive paclitaxel IV over 24 hours beginning on day 1 immediately followed by carboplatin IV over 2 hours immediately followed by topotecan IV over 24 hours Patients receive G-CSF sub-cutaneously SQ daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy If no evidence of disease is found during laparoscopy then exploratory laparotomy must also be performed
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or at time of recurrence until death
I Determine the safety and feasibility of multiple courses of high dose carboplatin paclitaxel and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma
II Determine the pathological complete response rate disease free survival and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study
Mobilization and harvest Within 8 weeks of surgical debulking patients receive cyclophosphamide IV over 1 hour followed 4 hours later by paclitaxel IV over 24 hours Patients receive filgrastim G-CSF subcutaneously SQ daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells
High dose chemotherapy and transplantation 3 weeks after PBSC harvest Patients receive paclitaxel IV over 24 hours beginning on day 1 immediately followed by carboplatin IV over 2 hours immediately followed by topotecan IV over 24 hours Patients receive G-CSF sub-cutaneously SQ daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy If no evidence of disease is found during laparoscopy then exploratory laparotomy must also be performed
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or at time of recurrence until death
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02312 | REGISTRY | None | None |
| CDR0000067462 | None | None | None |
| GOG-9903 | OTHER | None | None |
| GOG-9903 | OTHER | None | None |