Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002559
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE III TRIAL OF TAXOL IFOSFAMIDE AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
Status:
COMPLETED
Status Verified Date:
2013-07
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
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of paclitaxel cisplatin and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of paclitaxel cisplatin and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy
Detailed Description:
OBJECTIVES
Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin
Determine the efficacy of this regimen as salvage therapy in these patients
OUTLINE This is a dose escalation study of paclitaxel
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6 Filgrastim G-CSF is administered subcutaneously SC on days 7-18 or until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity Additional patients receive paclitaxel at the MTD
After completion of chemotherapy some patients may undergo resection of residual masses
PROJECTED ACCRUAL A total of 18-43 patients will be accrued for this study within 2 years
Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin
Determine the efficacy of this regimen as salvage therapy in these patients
OUTLINE This is a dose escalation study of paclitaxel
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6 Filgrastim G-CSF is administered subcutaneously SC on days 7-18 or until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity Additional patients receive paclitaxel at the MTD
After completion of chemotherapy some patients may undergo resection of residual masses
PROJECTED ACCRUAL A total of 18-43 patients will be accrued for this study within 2 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-V94-0408 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063452 | REGISTRY | None | None |