| | Requirement |
| 1 | Patient must have histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) that is recurrent or has progressed after treatment. |
| 2 | Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20 mm or more with conventional techniques or as 10 mm or more with spiral CT scan. |
| 3 | Patient may have been treated with no more than two prior cytotoxic chemotherapy regimens for metastatic disease or as adjuvant therapy. Patients must have previously been treated with platinum-based therapy and a taxane. At least 4 weeks must have elapsed since prior chemotherapy and at least 6 weeks if the last regimen included mitomycin C. Patients receiving palliative radiation may be treated 2 weeks after completion of radiation provided any toxicities from that therapy have resolved to grade 1 or less. |
| 4 | Age >18 years or older. NSCLC is a disease of adults. Because no dosing or adverse event data are currently available on the use of E7389 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. |
| 5 | Life expectancy of greater than 3 months. |
| 6 | Zubrod performance status less than or equal to 2 (Karnofsky 60% or higher) |
| 7 | Patient must have normal organ function within 7 days of registration. |
| 8 | ANC more than or equal to 1,500/mcL; Platelet count more than or equal to 100,000 |
| 9 | Total bilirubin less than or equal to 2.0mg/dl |
| 10 | AST (SGOT) less than or equal to 2.5 x IULN; ALT (SGPT) less than or equal to 2.5 x IULN |
| 11 | Serum Creatinine within normal limits OR Creatinine Clearance more than or equal to 50 mL/min for patients with creatinine levels above institutional normal |
| 12 | Patient with asymptomatic treated brain metastasis is allowed provided the patient has been off steroids for greater than 2 weeks. Efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications. |
| 13 | The effects of E7389 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antitubulin agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. |
| 14 | Ability to understand and the willingness to sign a written informed consent document. |
| 1 | Patient who has had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to entering the study or those who have not recovered to grade 1 or less (excluding alopecia) from adverse events due to agents administered more than 4 weeks earlier |
| 2 | Patient receiving any other investigational agents. |
| 3 | Patient with known brain metastases that have been untreated or still requiring steroids. |
| 4 | History of allergic reactions attributed to compounds of similar chemical or biologic composition to E7389. |
| 5 | Patient with grade 2 or greater neuropathy. |
| 6 | Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements |
| 7 | Pregnant women because E7389 is an antitubulin agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7389, breastfeeding should be discontinued if the mother is treated with E7389 |
| 8 | HIV-positive patients on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with E7389. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. |
