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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Researchers from Memorial Sloan-Kettering Cancer Center are conducting a research study on a Chinese herbal medicine known as "Jin Fu Kang". We want to see if this can help patients with advanced lung cancer. Jin Fu Kang might reduce the growth of cancer or improve quality of life. You are eligible for this trial because your cancer has progressed after prior chemotherapy and your doctor has recommended further chemotherapy treatment.

Lung cancer that has been confirmed and that has spread is called advanced cancer. There is no known permanent cure for advanced lung cancer, but chemotherapy may temporarily shrink the cancer and improve the quality of patients' lives.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Docetaxel

Criteria

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.