Status:
COMPLETED
Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
Detailed Description
Jin Fu Kang is a herbal medicine specially developed in China for the treatment of lung cancer. It is based on a traditional medicine that is widely used and appears to be safe. Although clinical tria...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00260026
Start Date
November 1 2004
End Date
January 1 2007
Last Update
January 26 2007
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021