Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02693717
Status:
TERMINATED
Last Update Posted:
2021-05-20
First Post:
2016-02-18
Brief Title:
Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial to Evaluate Pemetrexed Clinical Responses in Relation to Tumor MTAP Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was closed due to the changing efficacy of treatments for metastatic urothelial cancer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well pemetrexed disodium works in treating patients with previously treated urothelial cancer that has spread from the primary site place where it started to other places in the body Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
To determine the objective response rates ORR to pemetrexed disodium pemetrexed in patients with MTAP-deficient metastatic bladder cancer
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed
II To determine the overall survival OS for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed
III Evaluate the toxicity of pemetrexed therapy for patients with MTAP-deficient metastatic bladder cancer
IV Collect blood urine and tissue for future translational studies
OUTLINE
Patients receive pemetrexed disodium intravenously IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 weeks and then every 3 months for 5 years
To determine the objective response rates ORR to pemetrexed disodium pemetrexed in patients with MTAP-deficient metastatic bladder cancer
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed
II To determine the overall survival OS for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed
III Evaluate the toxicity of pemetrexed therapy for patients with MTAP-deficient metastatic bladder cancer
IV Collect blood urine and tissue for future translational studies
OUTLINE
Patients receive pemetrexed disodium intravenously IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 weeks and then every 3 months for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2016-00390 | REGISTRY | None | None |
| 2015-0592 | OTHER | None | None |
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |