NCT00415324

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 20, 2014

Status Verified

April 1, 2014

Enrollment Period

7.4 years

First QC Date

December 20, 2006

Last Update Submit

May 19, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0

    28 days

Secondary Outcomes (2)

  • Survival

    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

    Up to 8 weeks

Study Arms (1)

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.

Drug: eribulin mesylateDrug: cisplatinOther: laboratory biomarker analysisOther: pharmacological study

Interventions

eribulin mesylateDRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog
Arm 1
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Arm 1
laboratory biomarker analysisOTHER

correlative study

Arm 1
pharmacological studyOTHER

correlative study

Also known as: pharmacological studies
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

eribulinCisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Marianna Koczywas

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

May 1, 2014

Last Updated

May 20, 2014

Record last verified: 2014-04

Locations

US(4)