Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005047
Status:
TERMINATED
Last Update Posted:
2017-06-08
First Post:
2000-04-06
Brief Title:
4B951 Combination Chemotherapy in Treating Patients With Bladder Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
MVAC Methotrexate Vinblastine Adriamycin and Cisplatin in Organ-Confined Bladder Cancer Based on p53 Status
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual was halted on the basis of the Data and Safety Monitoring Board review of a futility analysis
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 whether combination chemotherapy is more effective than observation alone in treating bladder cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with bladder cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with bladder cancer
Detailed Description:
OBJECTIVES
Compare the recurrence-free and overall survival in patients with transitional cell carcinoma of the bladder with p53 gene alterations treated with methotrexate vinblastine doxorubicin and cisplatin vs observation alone
Compare the recurrence-free and overall survival in patients with or without p53 gene alterations treated with observation alone
Examine the expression of p53 and other genes particularly RB p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy in these patients
Correlate p53 mutational gene status with p53 protein expression by immunohistochemistry outcome recurrence-free and overall survival response to chemotherapy and expression of key molecules in the p53-mediated apoptotic pathway in patients treated with this regimen vs observation alone
OUTLINE This is a randomized multicenter study Patients are assigned to 1 of 2 treatment groups based on the status of the p53 gene in the bladder tumor
Group A p53 gene alteration defined by greater than 10 nuclear reactivity Patients are stratified according to age under 65 vs 65 and over stage P1 vs P2a vs P2b grade 1 or 2 vs 3 or 4 and p21 status Patients are randomized to 1 of 2 treatment arms within 10 weeks after radical cystectomy and bilateral pelvic lymphadenectomy and within 2 weeks after registration
Arm I Within 2 weeks after randomization patients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and doxorubicin IV and cisplatin IV on day 2 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery
Patients who are eligible for randomization but decline to be randomized undergo observation for recurrence
Group B p53 gene normal defined by less than 10 nuclear reactivity Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study within 475 years
Compare the recurrence-free and overall survival in patients with transitional cell carcinoma of the bladder with p53 gene alterations treated with methotrexate vinblastine doxorubicin and cisplatin vs observation alone
Compare the recurrence-free and overall survival in patients with or without p53 gene alterations treated with observation alone
Examine the expression of p53 and other genes particularly RB p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy in these patients
Correlate p53 mutational gene status with p53 protein expression by immunohistochemistry outcome recurrence-free and overall survival response to chemotherapy and expression of key molecules in the p53-mediated apoptotic pathway in patients treated with this regimen vs observation alone
OUTLINE This is a randomized multicenter study Patients are assigned to 1 of 2 treatment groups based on the status of the p53 gene in the bladder tumor
Group A p53 gene alteration defined by greater than 10 nuclear reactivity Patients are stratified according to age under 65 vs 65 and over stage P1 vs P2a vs P2b grade 1 or 2 vs 3 or 4 and p21 status Patients are randomized to 1 of 2 treatment arms within 10 weeks after radical cystectomy and bilateral pelvic lymphadenectomy and within 2 weeks after registration
Arm I Within 2 weeks after randomization patients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and doxorubicin IV and cisplatin IV on day 2 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery
Patients who are eligible for randomization but decline to be randomized undergo observation for recurrence
Group B p53 gene normal defined by less than 10 nuclear reactivity Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study within 475 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 |
|---|---|---|---|
| U10CA032102 | NIH | NCIC-CTG | httpsreporternihgovquickSearchU10CA032102 |
| LAC-USC-4B951 | OTHER | None | None |
| SWOG-4B951 | OTHER | None | None |
| NCI-G00-1715 | OTHER | None | None |
| NYU-9852 | OTHER | None | None |
| CAN-NCIC-BL10 | OTHER | None | None |
| CCCWFU-88198 | None | None | None |