Ignite Creation Date:
2024-05-05 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00551122
Status:
UNKNOWN
Last Update Posted:
2013-01-23
First Post:
2007-10-25
Brief Title:
Gemcitabine Paclitaxel Ifosfamide and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors
Sponsor:
University of Southampton
Organization:
University of Southampton
Study Overview
Official Title:
Phase III Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
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:
GemTIP
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine paclitaxel ifosfamide and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel ifosfamide and cisplatin and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors
PURPOSE This phase III trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel ifosfamide and cisplatin and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors
Detailed Description:
OBJECTIVES
To determine the maximum tolerated dose MTD of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel ifosfamide and cisplatin with growth factor support Gem-TIP in patients with progressive or relapsed metastatic germ cell tumors
To compare the MTD of the Gem-TIP regimen with the MTD determined in a previous Medical Research Council study of TIP alone
To compare the degree of dose intensification achieved with Gem-TIP chemotherapy with that achieved in the prior study of TIP chemotherapy alone
To assess the dose of gemcitabine hydrochloride that can be delivered with the TIP regimen in these patients
To measure response rates and failure-free survival of patients treated with Gem-TIP alone
To assess the utility of PET scanning after Gem-TIP chemotherapy in these patients
OUTLINE This is a multicenter phase I dose-escalation study of gemcitabine hydrochloride followed by a phase II study
Phase I Patients receive gemcitabine hydrochloride IV over 30 minutes and paclitaxel IV over 3 hours on day 1 cisplatin IV over 4 hours on days 1-5 and ifosfamide IV over 1 hour on days 2-6 Patients also receive filgrastim or lenograstim G-CSF subcutaneously SC on days 7-18 or until blood counts recover OR pegfilgrastim SC once on day 6 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Phase II An additional cohort of 14 patients is treated as in phase I at the MTD determined in phase I
After completion of study therapy patients are followed periodically for up to 1 year and then at the investigators discretion
To determine the maximum tolerated dose MTD of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel ifosfamide and cisplatin with growth factor support Gem-TIP in patients with progressive or relapsed metastatic germ cell tumors
To compare the MTD of the Gem-TIP regimen with the MTD determined in a previous Medical Research Council study of TIP alone
To compare the degree of dose intensification achieved with Gem-TIP chemotherapy with that achieved in the prior study of TIP chemotherapy alone
To assess the dose of gemcitabine hydrochloride that can be delivered with the TIP regimen in these patients
To measure response rates and failure-free survival of patients treated with Gem-TIP alone
To assess the utility of PET scanning after Gem-TIP chemotherapy in these patients
OUTLINE This is a multicenter phase I dose-escalation study of gemcitabine hydrochloride followed by a phase II study
Phase I Patients receive gemcitabine hydrochloride IV over 30 minutes and paclitaxel IV over 3 hours on day 1 cisplatin IV over 4 hours on days 1-5 and ifosfamide IV over 1 hour on days 2-6 Patients also receive filgrastim or lenograstim G-CSF subcutaneously SC on days 7-18 or until blood counts recover OR pegfilgrastim SC once on day 6 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Phase II An additional cohort of 14 patients is treated as in phase I at the MTD determined in phase I
After completion of study therapy patients are followed periodically for up to 1 year and then at the investigators discretion
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 |
|---|---|---|---|
| EUDRACT-2004-004804-19 | None | None | None |
| USCTU-UR1002-GEM-TIP | None | None | None |
| EU-20769 | None | None | None |