NCT00400829

Brief Summary

This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Typical duration for phase_2

Geographic Reach
1 country

2 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

November 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 7, 2015

Completed
Last Updated

January 7, 2015

Status Verified

October 1, 2013

Enrollment Period

4.2 years

First QC Date

November 16, 2006

Results QC Date

December 23, 2014

Last Update Submit

December 23, 2014

Conditions

Recurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (CR or PR) According to RECIST Criteria

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Tumor measurements repeated every 6 weeks

Secondary Outcomes (2)

  • Overall Survival

    From start of treatment to death from any cause, assessed up to 5 years

  • Progression Free Survival

    From start of treatment to the time of documented progression, assessed up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: eribulin mesylate

Interventions

eribulin mesylateDRUG

Given IV

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

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIB or IV disease
  • Recurrent or progressive disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Must have received prior treatment with platinum-based therapy and a taxane
  • Asymptomatic brain metastasis allowed provided off steroids for \> 2 weeks
  • Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%
  • Life expectancy \> 3 months
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • +12 more criteria

You may not qualify if:

  • Absolute neutrophil count ≥ 1,500/mm³
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

eribulin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
DCC Project Administrator
Organization
California Cancer Consortium
CCCP@coh.org
626-256-4673

Study Officials

  • Barbara Gitlitz

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 7, 2015

Results First Posted

January 7, 2015

Record last verified: 2013-10

Locations

US(2)