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E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00400829
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

November 16, 2006
November 17, 2006
December 23, 2014
January 7, 2015
January 7, 2015
November 2006
January 2011   (Final data collection date for primary outcome measure)
Objective Response Rate (CR or PR) According to RECIST Criteria [ Time Frame: Tumor measurements repeated every 6 weeks ]
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
Objective response rate as measured by RECIST criteria
Complete list of historical versions of study NCT00400829 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: From start of treatment to death from any cause, assessed up to 5 years ]
    Will be estimated using the product-limit method of Kaplan and Meier.
  • Progression Free Survival [ Time Frame: From start of treatment to the time of documented progression, assessed up to 5 years ]
    Will be estimated using the product-limit method of Kaplan and Meier.
  • Overall Survival
  • Time to progression
  • Toxicity profile
Not Provided
Not Provided
 
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane
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.

OBJECTIVES:

I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.

II. Evaluate the time to progression and overall survival of patients treated with this drug.

III. Evaluate the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 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.

After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog
Experimental: Arm I
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.
Intervention: Drug: eribulin mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
39
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • No neuropathy ≥ grade 2
  • No uncontrolled 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 situations that would preclude study compliance
  • No other concurrent investigational agents
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered
  • No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant setting
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion Criteria:

  • Absolute neutrophil count ≥ 1,500/mm³
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00400829
NCI-2009-01159
NCI-2009-01159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000514516
PHII-74 ( Other Identifier: City of Hope )
7437 ( Other Identifier: CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Barbara Gitlitz City of Hope Medical Center
National Cancer Institute (NCI)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP