Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002919
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE II TRIAL OF THE COMBINATION OF TRANSURETHRAL RESECTION AND NEOADJUVANT CHEMOTHERAPY FOR PATIENTS WITH INVASIVE UROTHELIAL TRACT TUMORS SELECTED BY STAGE AND P53 NUCLEAR EXPRESSION
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 Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with stage II bladder cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with stage II bladder cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of combination chemotherapy with methotrexate vinblastine doxorubicin and cisplatin MVAC following aggressive transurethral resection of bladder tumors in patients with stage II transitional cell carcinoma of the bladder without nuclear overexpression of mutant p53 II Determine the proportion of patients treated with this regimen in whom bladder preservation rather than radical cystectomy is possible
OUTLINE All patients undergo complete or near complete transurethral resection of the bladder tumor at entry or within 6 weeks prior to entry Upon confirmation of staging and histology patients receive combination chemotherapy with methotrexate vinblastine doxorubicin and cisplatin MVAC every 21 days for 4 courses Subcutaneous G-CSF is given with each course Patients with a complete response after chemotherapy proceed to intravesical therapy or observation those with a partial response stable disease or progression proceed to definitive surgery
PROJECTED ACCRUAL 30 patients will be entered over approximately 18 months
OUTLINE All patients undergo complete or near complete transurethral resection of the bladder tumor at entry or within 6 weeks prior to entry Upon confirmation of staging and histology patients receive combination chemotherapy with methotrexate vinblastine doxorubicin and cisplatin MVAC every 21 days for 4 courses Subcutaneous G-CSF is given with each course Patients with a complete response after chemotherapy proceed to intravesical therapy or observation those with a partial response stable disease or progression proceed to definitive surgery
PROJECTED ACCRUAL 30 patients will be entered over approximately 18 months
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 |
|---|---|---|---|
| NCI-H97-1118 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065305 | REGISTRY | None | None |