Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003376
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Trial of Methotrexate Vinblastine Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium
Status:
COMPLETED
Status Verified Date:
2023-06
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 if four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating advanced cancer of the urothelium
PURPOSE Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium
PURPOSE Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium
Detailed Description:
OBJECTIVES I Compare the objective response rate duration of remission overall survival and quality of life of patients with progressing regional or metastatic transitional cell carcinoma or mixed histologies with a component of transitional cell carcinoma of the urothelium treated with methotrexate vinblastine doxorubicin and cisplatin vs carboplatin and paclitaxel II Compare the relative toxic effects of these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and cisplatin IV over 2 hours and doxorubicin IV on day 2 Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression Arm II Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression Quality of life is assessed before treatment before courses 2 and 4 at 4 weeks after last course and at 10 months Patients are followed every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 330 patients will be accrued for this study within 33 years
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and cisplatin IV over 2 hours and doxorubicin IV on day 2 Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression Arm II Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression Quality of life is assessed before treatment before courses 2 and 4 at 4 weeks after last course and at 10 months Patients are followed every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 330 patients will be accrued for this study within 33 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 |
|---|---|---|---|
| GUMC-01011 | None | None | None |
| E4897 | None | None | None |
| CLB-99908 | None | None | None |