Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer

Inclusion Criteria:

-Patients must meet all of the following inclusion criteria:

• Pathologic confirmation of stage III or IV NSCLC.
• Docetaxel therapy for cancer is clinically indicated.
• KPS>=60% *ANC<1,000/mcl and Platelets<100/mcl

Exclusion Criteria:

-Patients must meet none of the following exclusion criteria:

• WBC< 4,000/µl, hemoglobin < 10 g/dl, platelet count < 100,000/µl, total bilirubin > ULN, AST >1.5 x ULN, alkaline phosphatase > 2.5 x ULN, creatinine > 1.5 mg/dl or creatinine clearance < 50 ml/min/1.7 m2), (ANC > 10,000/µl)
• Prior docetaxel
• Patient must have recovered from all previous treatment-related toxicity
• Concurrent use of any botanicals for anticancer intent
• Use of Jin Fu Kang or any of its constituent botanicals in the previous three weeks.
• History of allergy to any of the constituent botanicals in Jin Fu Kang.
• Pregnant or lactating women or women of childbearing potential not using effective contraception. A negative pregnancy test must be documented during the screening period for women of childbearing potential.
• Concurrent active cancer.
• Concurrent use of immunosuppressives: as an immunostimulant, astragalus-containing products are contraindicated for patients on immunosuppressive therapy.