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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (CR or PR) according to RECIST criteria

Outcome Description:

Exact 95% confidence intervals will be calculated for this estimate (reflecting the interim analysis).

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Barbara Gitlitz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01159

NCT ID:

NCT00400829

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
City of HopeDuarte, California  91010