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

Phase 2

Completed

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

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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm I	eribulin mesylate	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (CR or PR) According to RECIST Criteria	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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	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.

Locations (2): City of Hope
🇺🇸
Duarte, California, United States
University of Pittsburgh Cancer Institute
🇺🇸
Pittsburgh, Pennsylvania, United States