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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Given IV
City of Hope
Duarte, California, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
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
Time frame: Tumor measurements repeated every 6 weeks
Overall Survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: 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.
Time frame: From start of treatment to the time of documented progression, assessed up to 5 years
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