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

NCT ID: NCT00400829

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-01-31

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.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

eribulin mesylate

Intervention Type: DRUG

Given IV

Interventions

eribulin mesylate

Given IV

Intervention Type: DRUG

Other Intervention Names

B1939; E7389; ER-086526; halichrondrin B analog

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Gitlitz

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope

Duarte, California, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2009-01159

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000514516

Identifier Type: -

Identifier Source: secondary_id

PHII-74

Identifier Type: OTHER

Identifier Source: secondary_id

7437

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-01159

Identifier Type: -

Identifier Source: org_study_id