Clinical trial NCT00415324: Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
Official title: A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-12-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* AST and ALT =\< 2.5 times upper limit of normal
* No prior cumulative cisplatin dose \> 300 mg/m\^2
* No preexisting neuropathy \<= grade 2
* Not pregnant or nursing

Primary outcomes:
measure: Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
timeFrame: 28 days
Secondary outcomes:
measure: Survival
timeFrame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
measure: Time to failure
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of Southern California/Norris Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California at Davis Cancer Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Marianna Koczywas
role: PRINCIPAL_INVESTIGATOR
References: