Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003105
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Trial of Sequential DoxorubicinGemcitabine AG and Ifosfamide Paclitaxel and Cisplatin ITP Chemotherapy AG-ITP in Patients With Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
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 in treating patients with metastatic or locally advanced bladder cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of doxorubicin gemcitabine and filgrastim G-CSF followed by ifosfamide paclitaxel cisplatin and G-CSF in patients with metastatic or locally advanced transitional cell carcinoma of the urothelium
Determine the efficacy of this regimen in this patient population
OUTLINE This is a dose-escalation study of gemcitabine
Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim G-CSF subcutaneously SC on days 3-11 Treatment repeats every 2 weeks for 5 courses
After completion of the fifth course patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 ifosfamide IV over 1 hour on days 1-3 and G-CSF SC daily on days 6-17 Treatment repeats every 3-4 weeks for 4 courses
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for phase I and a maximum of 10 patients will be accrued for phase II within 2-3 years
Determine the safety and toxicity of doxorubicin gemcitabine and filgrastim G-CSF followed by ifosfamide paclitaxel cisplatin and G-CSF in patients with metastatic or locally advanced transitional cell carcinoma of the urothelium
Determine the efficacy of this regimen in this patient population
OUTLINE This is a dose-escalation study of gemcitabine
Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim G-CSF subcutaneously SC on days 3-11 Treatment repeats every 2 weeks for 5 courses
After completion of the fifth course patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 ifosfamide IV over 1 hour on days 1-3 and G-CSF SC daily on days 6-17 Treatment repeats every 3-4 weeks for 4 courses
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for phase I and a maximum of 10 patients will be accrued for phase II within 2-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1339 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065841 | REGISTRY | None | None |