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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: eribulin mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given IV<br>* Other names: halichrondrin B analog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Will be estimated using the product-limit method of Kaplan and Meier. | From start of treatment to death from any cause, assessed up to 5 years | 
| Progression Free Survival | Will be estimated using the product-limit method of Kaplan and Meier. | From start of treatment to the time of documented progression, assessed up to 5 years |