Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01639521
Status:
WITHDRAWN
Last Update Posted:
2014-01-29
First Post:
2012-07-10
Brief Title:
Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate Vinblastine Doxorubicin Hydrochloride and Cisplatin in Treating Patients With Urothelial Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Randomized Phase II Trial Of Adjuvant Chemotherapy For Urothelial Carcinoma Comparing GC To Dose-Dense MVAC
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is about two chemotherapy study drug combinations regimens that are used for urothelial bladder or upper urinary tract cancer Both study drug regimens gemcitabine gemcitabine hydrochloride plus cisplatin and high-dose-intensity MVAC methotrexate vinblastine doxorubicin plus cisplatin are standard chemotherapy regimens Both regimens are used to treat people with urothelial cancer that has spread to other organs Both study drug regimens have been proven to be effective in lowering the risk of the cancer coming back but it is not known which regimen is the best This study hopes to learn whether there is a difference in the effectiveness and side effects of these two study drug regimens when they are given to people who have had their urothelial cancer completely removed
Detailed Description:
PRIMARY OBJECTIVES
To estimate the difference in the rate of unacceptable toxicity for dose-dense methotrexate vinblastine doxorubicin and cisplatin MVAC and gemcitabine and cisplatin GC in the adjuvant treatment of urothelial cancer
SECONDARY OBJECTIVES
To compare rates of disease recurrence at 3 years between dose-dense MVAC and GC
To determine whether molecular markers excision repair cross-complementing-1 ERCC-1 ribonucleoside-diphosphate reductase M-1 RRM-1 breast cancer 1 BRCA1 topoisomerase 2-alpha Top2A and protein 53 p53 can predict those patients more likely to benefit from chemotherapy
To investigate the potential utility of cytidine deaminase CDA ERCC-1 xeroderma pigmentosum group D XPD glutathione S-transferase P-1 GSTP-1 and glutathione S-transferase M-1 GSTM-1 as molecular markers which predict occurrence of significant toxicity during adjuvant chemotherapy for urothelial cancer
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive cisplatin intravenously IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM B Patients receive methotrexate IV on day 1 vinblastine IV doxorubicin hydrochloride IV cisplatin IV on day 2 and pegfilgrastim subcutaneously SC on day 3 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed up every 3 months for 3 years
To estimate the difference in the rate of unacceptable toxicity for dose-dense methotrexate vinblastine doxorubicin and cisplatin MVAC and gemcitabine and cisplatin GC in the adjuvant treatment of urothelial cancer
SECONDARY OBJECTIVES
To compare rates of disease recurrence at 3 years between dose-dense MVAC and GC
To determine whether molecular markers excision repair cross-complementing-1 ERCC-1 ribonucleoside-diphosphate reductase M-1 RRM-1 breast cancer 1 BRCA1 topoisomerase 2-alpha Top2A and protein 53 p53 can predict those patients more likely to benefit from chemotherapy
To investigate the potential utility of cytidine deaminase CDA ERCC-1 xeroderma pigmentosum group D XPD glutathione S-transferase P-1 GSTP-1 and glutathione S-transferase M-1 GSTM-1 as molecular markers which predict occurrence of significant toxicity during adjuvant chemotherapy for urothelial cancer
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive cisplatin intravenously IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM B Patients receive methotrexate IV on day 1 vinblastine IV doxorubicin hydrochloride IV cisplatin IV on day 2 and pegfilgrastim subcutaneously SC on day 3 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed up every 3 months for 3 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 |
|---|---|---|---|
| NCI-2012-00961 | REGISTRY | CTRP Clinical Trial Reporting Program | None |