Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423852
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2007-01-16
Brief Title:
Paclitaxel Ifosfamide and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Trial of Sequential PaclitaxelIfosfamide Followed by Dose-Escalated Dose-Intensive Carboplatin Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients
Status:
COMPLETED
Status Verified Date:
2016-04
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 such as paclitaxel ifosfamide and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy This may allow more chemotherapy to be given so that more tumor cells are killed
PURPOSE This phase III trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin
PURPOSE This phase III trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin
Detailed Description:
OBJECTIVES
Determine the safety of paclitaxel and ifosfamide followed by dose-escalated dose-intensive paclitaxel carboplatin and ifosfamide with autologous peripheral blood stem cell support in patients with cisplatin-resistant germ cell tumor Phase I
Determine the maximum tolerated dose of paclitaxel carboplatin and ifosfamide when given with a high-dose treatment program in these patients Phase I
Determine the efficacy of this regimen when given as salvage therapy in the second-line or third-line setting in terms of complete response in these patients Phase II
OUTLINE This is a phase I dose-escalation study of paclitaxel carboplatin and ifosfamide followed by a phase II open-label study
Phase I
Paclitaxel ifosfamide and autologous peripheral blood stem cell PBSC collection Patients receive paclitaxel IV over 3 hours on day 1 and ifosfamide IV over 2 hours on days 1-3 Patients undergo leukapheresis on days 11-13 Patients also receive filgrastim G-CSF subcutaneously SC twice daily beginning on day 3 and continuing until leukapheresis is completed Beginning on day 14 or 21 patients may receive a second course of paclitaxel ifosfamide and G-CSF Patients may also undergo additional leukapheresis
Paclitaxel carboplatin ifosfamide and autologous PBSC transplantation Patients receive paclitaxel IV over 3 hours high-dose carboplatin IV over 30 minutes and ifosfamide IV over 4 hours on days 1-3 Patients also receive G-CSF SC beginning on day 3 and continuing until blood counts recover Patients undergo reinfusion of autologous PBSCs on day 5 Treatment repeats every 21-28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel carboplatin and ifosfamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I with paclitaxel carboplatin and ifosfamide at the MTD determined in phase I
After completion of study treatment patients are followed periodically for 1 year and then annually thereafter
Determine the safety of paclitaxel and ifosfamide followed by dose-escalated dose-intensive paclitaxel carboplatin and ifosfamide with autologous peripheral blood stem cell support in patients with cisplatin-resistant germ cell tumor Phase I
Determine the maximum tolerated dose of paclitaxel carboplatin and ifosfamide when given with a high-dose treatment program in these patients Phase I
Determine the efficacy of this regimen when given as salvage therapy in the second-line or third-line setting in terms of complete response in these patients Phase II
OUTLINE This is a phase I dose-escalation study of paclitaxel carboplatin and ifosfamide followed by a phase II open-label study
Phase I
Paclitaxel ifosfamide and autologous peripheral blood stem cell PBSC collection Patients receive paclitaxel IV over 3 hours on day 1 and ifosfamide IV over 2 hours on days 1-3 Patients undergo leukapheresis on days 11-13 Patients also receive filgrastim G-CSF subcutaneously SC twice daily beginning on day 3 and continuing until leukapheresis is completed Beginning on day 14 or 21 patients may receive a second course of paclitaxel ifosfamide and G-CSF Patients may also undergo additional leukapheresis
Paclitaxel carboplatin ifosfamide and autologous PBSC transplantation Patients receive paclitaxel IV over 3 hours high-dose carboplatin IV over 30 minutes and ifosfamide IV over 4 hours on days 1-3 Patients also receive G-CSF SC beginning on day 3 and continuing until blood counts recover Patients undergo reinfusion of autologous PBSCs on day 5 Treatment repeats every 21-28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel carboplatin and ifosfamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I with paclitaxel carboplatin and ifosfamide at the MTD determined in phase I
After completion of study treatment patients are followed periodically for 1 year and then annually thereafter
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 |
|---|---|---|---|
| MSKCC-06077 | None | None | None |