Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365157
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2006-08-16
Brief Title:
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of E7389 Halichondrin B Analog NSC 707389 in Metastatic Urothelial Tract Cancer and Renal Insufficiency
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This phase III trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue locally advanced or to other places in the body metastaticand kidney dysfunction Drugs used in chemotherapy such as eribulin mesylate work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Chemotherapy drugs may have different effects in patients who have changes in their kidney function
Detailed Description:
PRIMARY OBJECTIVES
I To establish whether eribulin mesylate E7389 can be given safely to patients with moderate and severe renal dysfunction at 14 mgm2week the maximum tolerated dose MTD previously defined for patients with normal renal function on days 1 and 8 of a 21-day cycle Phase I II To characterize the pharmacokinetic PK profile of E7389 in patients with moderate and severe renal dysfunction Phase I III To determine the response rate of patients with advanced urothelial carcinomas to E7389 in the first-line setting Phase II IV To determine the 6-month progression-free survival and overall survival of patients with advanced urothelial carcinomas treated with E7389 Phase II V To document the toxicity associated with the administration of E7389 to patients with advanced urothelial carcinoma patients and varying degrees of renal dysfunction Phase II VI To determine the response rate of patients with advanced urothelial carcinomas to E7389 in the setting of progression after prior platinum-based chemotherapy for advanced or recurrent disease in two cohorts tubulin-inhibitor treated or tubulin-inhibitor naive tubulin inhibitors in common use for urothelial cancer include paclitaxel docetaxel and vinblastine Phase II per Amendment 6 VII To determine the 6-month progression-free survival and overall survival of patients with advanced urothelial carcinomas treated with E7389 after platinum-based therapy for recurrent or advanced disease Phase II per Amendment 6 VIII To document the toxicity associated with the administration of E7389 to patients with advanced urothelial carcinoma patients in the second line and later setting Phase II per Amendment 6 IX To compare men and women with advanced bladder cancer treated with E7389 with respect to toxicity of E7389 as classified by Common Terminology Criteria for Adverse Events CTCAE version v4 for i all hematologic toxicities ii all non- hematologic toxicities and iii the most frequently observed toxicities neutropenia anemia leucopenia infection Enrollment to additional females per Amendment 11 X To compare men and women with advanced bladder cancer treated with E7389 with respect to response to E7389 as evidenced by i disease control rate DCR defined as stable disease SDpartial response PRcomplete response CR at 12 weeks ii progression-free survival PFS and iii overall survival OS Enrollment to additional females per Amendment 11 XI To compare men and women with advanced bladder cancer treated with E7389 with respect to pharmacokinetics of E7389 Enrollment to additional females per Amendment 11 XII To compare men and women with advanced bladder cancer treated with E7389 with respect to tumoral expression of genes involved in the mechanism of action of E7389 including tubulin isotypes microtubule-associated protein 4 MAP4 and stathmin Enrollment to additional females per Amendment 11
OUTLINE
Patients receive eribulin mesylate intravenously IV over 1-2 minutes on days 1 and 8 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up monthly for 12 months and then every 3 months for up to 24 months
I To establish whether eribulin mesylate E7389 can be given safely to patients with moderate and severe renal dysfunction at 14 mgm2week the maximum tolerated dose MTD previously defined for patients with normal renal function on days 1 and 8 of a 21-day cycle Phase I II To characterize the pharmacokinetic PK profile of E7389 in patients with moderate and severe renal dysfunction Phase I III To determine the response rate of patients with advanced urothelial carcinomas to E7389 in the first-line setting Phase II IV To determine the 6-month progression-free survival and overall survival of patients with advanced urothelial carcinomas treated with E7389 Phase II V To document the toxicity associated with the administration of E7389 to patients with advanced urothelial carcinoma patients and varying degrees of renal dysfunction Phase II VI To determine the response rate of patients with advanced urothelial carcinomas to E7389 in the setting of progression after prior platinum-based chemotherapy for advanced or recurrent disease in two cohorts tubulin-inhibitor treated or tubulin-inhibitor naive tubulin inhibitors in common use for urothelial cancer include paclitaxel docetaxel and vinblastine Phase II per Amendment 6 VII To determine the 6-month progression-free survival and overall survival of patients with advanced urothelial carcinomas treated with E7389 after platinum-based therapy for recurrent or advanced disease Phase II per Amendment 6 VIII To document the toxicity associated with the administration of E7389 to patients with advanced urothelial carcinoma patients in the second line and later setting Phase II per Amendment 6 IX To compare men and women with advanced bladder cancer treated with E7389 with respect to toxicity of E7389 as classified by Common Terminology Criteria for Adverse Events CTCAE version v4 for i all hematologic toxicities ii all non- hematologic toxicities and iii the most frequently observed toxicities neutropenia anemia leucopenia infection Enrollment to additional females per Amendment 11 X To compare men and women with advanced bladder cancer treated with E7389 with respect to response to E7389 as evidenced by i disease control rate DCR defined as stable disease SDpartial response PRcomplete response CR at 12 weeks ii progression-free survival PFS and iii overall survival OS Enrollment to additional females per Amendment 11 XI To compare men and women with advanced bladder cancer treated with E7389 with respect to pharmacokinetics of E7389 Enrollment to additional females per Amendment 11 XII To compare men and women with advanced bladder cancer treated with E7389 with respect to tumoral expression of genes involved in the mechanism of action of E7389 including tubulin isotypes microtubule-associated protein 4 MAP4 and stathmin Enrollment to additional females per Amendment 11
OUTLINE
Patients receive eribulin mesylate intravenously IV over 1-2 minutes on days 1 and 8 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up monthly for 12 months and then every 3 months for up to 24 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 |
|---|---|---|---|
| UM1CA186717 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186717 |
| NCI-2009-00170 | REGISTRY | None | None |
| CDR0000492014 | None | None | None |
| PHII-75 | None | None | None |
| 7435 | OTHER | None | None |
| 7435 | OTHER | None | None |
| N01CM00038 | NIH | None | None |
| N01CM00071 | NIH | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62209 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| UM1CA186705 | NIH | None | None |