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

Completed · Phase 2

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

In brief

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.

Key facts

Study ID

NCT00400829

Run by

National Cancer Institute (NCI)

People needed

66

Starts

2006-11-01

Expected to finish

2011-01-01

Last updated by the study team

2015-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Absolute neutrophil count ≥ 1,500/mm³
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389

Where it is running

• City of Hope — Duarte, California, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.