Non-Small Cell Lung Cancer Clinical Trial
Official title:
Safety and Pharmacokinetic Study of Jin Fu Kang In Combination With Docetaxel for Patients With Previously Treated Non-Small Cell Lung Cancer
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the toxicity of Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer. | |||
Secondary | To determine whether Jin Fu Kang alters the pharmacokinetics of docetaxel. | |||
Secondary | To provide preliminary efficacy and survival data for Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer. |
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