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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00168 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PHI-55 | |||
| CDR0000518290 | |||
| PHI-55 | Other Identifier | City of Hope Medical Center | |
| 7427 | Other Identifier | CTEP | |
| U01CA062505 | U.S. NIH Grant/Contract | View source | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Primary Objectives:
I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eribulin mesylate | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. | From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks |
| Time to failure |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianna Koczywas | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope |
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| cisplatin | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | correlative study |
|
| pharmacological study | Other | correlative study |
|
|
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
| Up to 8 weeks |
| Duarte |
| California |
| 91010 |
| United States |
| University of Southern California/Norris Cancer Center | Los Angeles | California | 90033 | United States |
| University of California at Davis Cancer Center | Sacramento | California | 95817 | United States |
| ID | Term |
|---|---|
| C490954 | eribulin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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