A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
- Histologically confirmed locally advanced or metastatic NSCLC previously treated with
2 prior chemotherapy regimens (not including prior adjuvant therapy for stage I or II
- Disease recurrence or progression after prior therapy with a platinum-based and a
taxane-based regimen, given either concurrently or separately.
- Measurable disease. Measurable lesions should be outside the field of radiation.
Where measurable lesions are within a previously irradiated field, there must be
objective evidence of progression of the lesion prior to patient enrollment.
- Male or female patients greater than or equal to 18 years of age.
- ECOG performance status of 0 or 1.
- Must have adequate organ and immune system function as indicated by the following
laboratory values, obtained less than or equal to 2 weeks prior to registration: A.
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1,000,000,000. B.
Hemoglobin greater than or equal to 9.0 g/dL. C. Platelet count greater than or equal
to 100 x 1,000,000,000/L. D. Serum creatinine or calculated creatinine clearance less
than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min. E. Serum total
bilirubin within limits of normal values. F. AST and ALT less than or equal to 2
times the upper limit of normal (ULN). G. Alkaline phosphatase within limits of
- Anti-cancer therapy, major surgery, or irradiation must have been completed at least
3 weeks before enrollment in this study. Patient must have recovered from the acute
side effects incurred as a result of previous therapy.
- Female patients with childbearing potential must have a negative pregnancy test
within 7 days of study enrollment. Men and women of reproductive potential must use
an effective contraceptive method while enrolled in the study.
- Signed informed consent (includes HIPAA authorization).
- Patients with uncontrolled congestive heart failure or angina, patients with a
history of myocardial infarction within 2 months of enrollment, or patients with
cardiac functional capacity Class III or IV as defined by the New York Heart
- Previously treated with > 2 prior chemotherapy regimens for advanced or metastatic
- Prior radiotherapy to the only site of measurable disease.
- Known hypersensitivity to study drug or its analogs.
- Use of investigational agents within previous 30 days.
- Known, active infection, or known HIV positive or presence of an AIDS related
- Active secondary malignancy except minor skin cancers.
- Presence of symptomatic active brain metastases, including leptomeningeal
- Any significant concurrent disease or illness, or psychiatric disorders or alcohol or
chemical abuse that would, in the opinion of the investigator, compromise patient
safety or compliance, or interfere with the interpretation of study results.
- Pregnant or lactating females.