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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400829
• Other study ID #: NCI-2009-01159
• Secondary ID: NCI-2009-01159CD
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2006
• Last updated: December 23, 2014
• Start date: November 2006
• Est. completion date: January 2011

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• eribulin mesylate
Given IV

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No