Status:
COMPLETED
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, wo...
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...
Eligibility Criteria
Inclusion
- 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
- Absolute neutrophil count ≥ 1,500/mm³
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00400829
Start Date
November 1 2006
End Date
January 1 2011
Last Update
January 7 2015
Active Locations (2)
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1
City of Hope
Duarte, California, United States, 91010
2
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232