Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01031420
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2009-12-03
Brief Title:
Dose Dense MVAC for Muscle Invasive Bladder Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Trial of Neoadjuvant Dose Dense MVAC in Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tract
Status:
COMPLETED
Status Verified Date:
2019-08
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:
Standard treatment for early stage bladder cancer is chemotherapy with methotrexate M vinblastine V adriamycin A and cisplatin C followed by surgical removal of any remaining cancer and the bladder with the intent of cure The M V chemotherapy is usually given every 14 days with the AC given along each 28 days This study looks at giving the same drugs at the same doses closer together all drugs every 14 days with the support of growth factor medication to promote growth of the white blood cells and platelets and allow chemotherapy to be finished sooner and surgery to be done sooner
Detailed Description:
Primary Objective To assess the rate of complete response pT0 at cystectomy or ureterectomy following preoperative dose dense MVAC DD-MVAC in patients with muscle invasive urothelial carcinoma of the bladder or high grade upper tract urothelial carcinoma
Secondary Objectives To assess the toxicity profile of DD-MVAC when given in the neoadjuvant setting To define the number of patients who complete all three cycles of treatment without dose reduction and to compare incidence of toxicity to the historical standard described by Grossman et al To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD-MVAC To compare complete response rates between the following subgroups of study patients Among bladder patients Clinical N0 versus N1 Appendix B Among bladder patients T2 stage without high risk features versus T2 with high risk features plus those with T2 stage
Three 14 day cycles of
Methotrexate 30 mgm2 IV push or infusion over 2-3 minutes Day 1
Vinblastine 3 mgm2 Slow IV push or infusion over Day 1
Doxorubicin 30 mgm2 Slow IV push or infusion over 15 minutes Day 1
Cisplatin 70 mgm2 IV infusion over 4 hours Note May divide dose over two sequential days 35 mgm2d x 2 days if creatinine clearance 50-59 mLmin Day 1 or divided over Day 1 and Day 2
Pegfilgrastim 6 mg subcutaneous SQ 24-48 hours after completion of chemotherapy
Followed in 4-8 weeks by radical cystectomyureterectomy
Secondary Objectives To assess the toxicity profile of DD-MVAC when given in the neoadjuvant setting To define the number of patients who complete all three cycles of treatment without dose reduction and to compare incidence of toxicity to the historical standard described by Grossman et al To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD-MVAC To compare complete response rates between the following subgroups of study patients Among bladder patients Clinical N0 versus N1 Appendix B Among bladder patients T2 stage without high risk features versus T2 with high risk features plus those with T2 stage
Three 14 day cycles of
Methotrexate 30 mgm2 IV push or infusion over 2-3 minutes Day 1
Vinblastine 3 mgm2 Slow IV push or infusion over Day 1
Doxorubicin 30 mgm2 Slow IV push or infusion over 15 minutes Day 1
Cisplatin 70 mgm2 IV infusion over 4 hours Note May divide dose over two sequential days 35 mgm2d x 2 days if creatinine clearance 50-59 mLmin Day 1 or divided over Day 1 and Day 2
Pegfilgrastim 6 mg subcutaneous SQ 24-48 hours after completion of chemotherapy
Followed in 4-8 weeks by radical cystectomyureterectomy
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-2010-01910 | REGISTRY | NCI Clinical Trials Reporting Office | None |