| Inclusion Criteria: | Histologically or cytologically confirmed diagnosis of NSCLC.
Stage IIIB or IV disease that is not amenable to either surgery of curative intent or radiation therapy. Refer to Protocol Attachment JEAM.2.
If the patient has had prior radiation therapy, lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy.
If the patient had prior radiation therapy, patient has fully recovered from any toxicity of the radiotherapy.
If the patient had prior radiation therapy, radiotherapy was completed at least 2 weeks prior to randomization.
At least one unidimensionally measurable lesion meeting RECIST (at least 10 mm in longest diameter by spiral CT or at least 20 mm by standard techniques- (PET scans and ultrasounds are not permitted methods of tumor measurements under this protocol).
Performance status of equal to or less than 1 on the ECOG Performance Status Scale (refer to Protocol Attachment JEAM.3).
Adequate bone marrow reserve: ANC equal to or greater than 1.5 x 10(9)/L, platelets equal to or greater than 100 x 10(9)/L, and hemoglobin equal to or greater than 9 g/dL. Patients may receive erythorcyte transfusion to achieve this hemoglobin level at the discretion of the investigator.
Adequate hepatic function: bilirubin equal to or less than 1.5 x ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase equal to or less than 3.0 x ULN. (AP, AST, & ALT equal to or less than 5 x ULN is acceptable if liver has tumor involvement). Pts. may have endoscopic or radiologic stenting to treat biliary obstructions. If so, bili must return to equal to or less than 1.5 x ULN with AP, AST, and ALT to euqal to or less than 5x ULN prior to enrollment.
Adequate renal function: calculated creatinine clearance equal to or greater than 50 mL/min per Cockcroft and Gault formula (refer to Protocol Attachment JEAM.5)
Patient compliance and geographic proximity (investigator's discretion) that allows adequate follow-up.
Signed informed consent from patient.
Males or females of at least 18 years of age.
Females must be surgically sterile or postmenopausal or must abstain from sexual activity or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period. Females of childbearing potential must test negative for pregnancy at enrollment based on serum pregnancy and must not be lactating.
Males must be surgically sterile or must abstain from sexual activity or must utilize a medically approved contraceptive method during and for 3 months after the treatment period. |