Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00415324

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2006-12-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed malignant solid tumor
• Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
• No known active brain metastases
• Life expectancy > 3 months
• ECOG performance status 0-2
• Bilirubin normal
• No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
• Negative pregnancy test
• Fertile patients must use effective contraception
• Recovered from prior therapy
• No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
• No prior targeted therapy within the past 4 weeks
• No prior immunotherapy within the past 4 weeks
• No prior radiotherapy within the past 4 weeks.
• No more than 2 prior chemotherapy regimens for advanced solid tumors.
• No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
• No concurrent antiretroviral therapy for HIV-positive patients.
• No other concurrent anticancer agents or therapies.
• Tumor has spread to other parts of the body or cannot be removed by surgery.
• More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
• No more than two previous chemotherapy regimens for advanced solid tumor.
• WBC >= 3,000/mm\^3
• Platelet count >= 100,000/mm\^3
• Creatinine clearance >= 60 mL/min
• Absolute neutrophil count >= 1,500/mm³

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• City of Hope — Duarte, California, United States
• University of Southern California/Norris Cancer Center — Los Angeles, California, United States
• University of California at Davis Cancer Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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