Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014274
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase IIIII Study Assessing GemcitabineCarboplatin And MethotrexateCarboplatinVinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy
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:
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 It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium
PURPOSE Randomized phase IIIII trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium
PURPOSE Randomized phase IIIII trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium
Detailed Description:
OBJECTIVES
Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate carboplatin and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy
Compare the toxicity and acute and intermediate 1-2 years side effects of these regimens in these patients
Compare the complete response rates progression-free survival and overall survival of patients treated with these regimens
Compare the symptoms and quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive methotrexate IV and vinblastine IV on days 1 15 and 22 and carboplatin IV over 1 hour on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mLmin or creatinine greater than 2 mgdL
Patients in either arm who achieve a complete response CR receive 2 additional courses of chemotherapy beyond CR
Quality of life is assessed at baseline after every 2 courses of chemotherapy and within 6 weeks of completion of therapy
Patients are followed within 6 weeks every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 156 patients 78 per treatment arm will be accrued for the phase II portion of this study A total of 225 patients will be accrued for the phase II III portions of this study within 5 years
Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate carboplatin and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy
Compare the toxicity and acute and intermediate 1-2 years side effects of these regimens in these patients
Compare the complete response rates progression-free survival and overall survival of patients treated with these regimens
Compare the symptoms and quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive methotrexate IV and vinblastine IV on days 1 15 and 22 and carboplatin IV over 1 hour on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mLmin or creatinine greater than 2 mgdL
Patients in either arm who achieve a complete response CR receive 2 additional courses of chemotherapy beyond CR
Quality of life is assessed at baseline after every 2 courses of chemotherapy and within 6 weeks of completion of therapy
Patients are followed within 6 weeks every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 156 patients 78 per treatment arm will be accrued for the phase II portion of this study A total of 225 patients will be accrued for the phase II III portions of this study within 5 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 |
|---|---|---|---|
| EORTC-GU-30986 | None | None | None |