Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003342
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial of Dose-Dense Gemcitabine Doxorubicin Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function
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 This phase I trial is studying the side effects of giving gemcitabine doxorubicin and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function
PURPOSE This phase I trial is studying the side effects of giving gemcitabine doxorubicin and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly schedule given in sequence after gemcitabine and doxorubicin in patients with renal impairment and metastatic or locally advanced transitional cell carcinoma of the urothelium
Observe the outcome of this sequential systemic chemotherapy in these patients or following surgical resection as adjuvant therapy in patients in whom poor renal function precludes the use of cisplatin-based chemotherapy
OUTLINE This is a dose escalation study of carboplatin
Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1 3 5 7 and 9 Filgrastim G-CSF is given subcutaneously on days 3 through 10 of each 2-week course On week 11 patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks
Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin If any patient experiences dose limiting toxicity DLT then 6 patients are entered at that dose level If 3 patients experience DLT at any dose level the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level
Patients are evaluated at week 16 and at end of study
PROJECTED ACCRUAL There will be 18-30 patients accrued into this study over 9-15 months
Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly schedule given in sequence after gemcitabine and doxorubicin in patients with renal impairment and metastatic or locally advanced transitional cell carcinoma of the urothelium
Observe the outcome of this sequential systemic chemotherapy in these patients or following surgical resection as adjuvant therapy in patients in whom poor renal function precludes the use of cisplatin-based chemotherapy
OUTLINE This is a dose escalation study of carboplatin
Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1 3 5 7 and 9 Filgrastim G-CSF is given subcutaneously on days 3 through 10 of each 2-week course On week 11 patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks
Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin If any patient experiences dose limiting toxicity DLT then 6 patients are entered at that dose level If 3 patients experience DLT at any dose level the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level
Patients are evaluated at week 16 and at end of study
PROJECTED ACCRUAL There will be 18-30 patients accrued into this study over 9-15 months
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 |
|---|---|---|---|
| MSKCC-97114 | None | None | None |
| NCI-G98-1438 | None | None | None |