Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470366
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2007-05-03
Brief Title:
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Paclitaxel Ifosfamide and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients
Status:
COMPLETED
Status Verified Date:
2016-06
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 cisplatin ifosfamide and paclitaxel 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 Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy
PURPOSE This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors
PURPOSE This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors
Detailed Description:
OBJECTIVES
Determine the efficacy of chemotherapy comprising paclitaxel ifosfamide and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors
Determine the safety of this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2 cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5 and pegfilgrastim subcutaneously on day 6 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Some patients may required surgery after chemotherapy and if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression these patients may receive 1-2 more courses of chemotherapy after surgery
After completion of study treatment patients are followed up at 28 days and then every 2 months for up to 1 year
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
Determine the efficacy of chemotherapy comprising paclitaxel ifosfamide and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors
Determine the safety of this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2 cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5 and pegfilgrastim subcutaneously on day 6 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Some patients may required surgery after chemotherapy and if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression these patients may receive 1-2 more courses of chemotherapy after surgery
After completion of study treatment patients are followed up at 28 days and then every 2 months for up to 1 year
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
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-07044 | None | None | None |