Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041106
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-07-08
Brief Title:
Gefitinib Plus Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of Cisplatin Gemcitabine And ZD 1839 IRESSA IND 61187 NSC 715055 For The Treatment Of Advanced Urothelial Tract Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor Combining chemotherapy with gefitinib may kill more tumor cells Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium
Detailed Description:
PRIMARY OBJECTIVES
I To describe the overall response proportion in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine gemcitabine hydrochloride and ZD1839 gefitinib given on a 21 day schedule followed by maintenance ZD1839
SECONDARY OBJECTIVES
I To describe the time to progression progression-free survival and overall survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839
II To evaluate the effect of epidermal growth factor receptor EGFR expression level on overall response rate and progression-free survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839
III To assess the toxicity of the combination of cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839 in patients with advanced carcinoma of the urothelial tract
OUTLINE This is a multicenter study
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1 Patients also receive gefitinib orally PO once daily QD beginning on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission partial remission or maintain stable disease continue gefitinib PO QD for 5 years or until disease progression or unacceptable toxicity occurs
Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse
I To describe the overall response proportion in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine gemcitabine hydrochloride and ZD1839 gefitinib given on a 21 day schedule followed by maintenance ZD1839
SECONDARY OBJECTIVES
I To describe the time to progression progression-free survival and overall survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839
II To evaluate the effect of epidermal growth factor receptor EGFR expression level on overall response rate and progression-free survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839
III To assess the toxicity of the combination of cisplatin gemcitabine and ZD1839 given on a 21 day schedule followed by maintenance ZD1839 in patients with advanced carcinoma of the urothelial tract
OUTLINE This is a multicenter study
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1 Patients also receive gefitinib orally PO once daily QD beginning on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission partial remission or maintain stable disease continue gefitinib PO QD for 5 years or until disease progression or unacceptable toxicity occurs
Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-90102 | None | None | None |
| CDR0000069443 | None | None | None |