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Safety and Pharmacokinetic Study of Jin Fu Kang In Combination With Docetaxel for Patients With Previously Treated Non-Small Cell Lung Cancer


Phase 2
N/A
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Safety and Pharmacokinetic Study of Jin Fu Kang In Combination With Docetaxel for Patients With Previously Treated Non-Small Cell Lung Cancer


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 trials in China suggest that Jin Fu Kang may be of benefit, it has never
been researched in patients with lung cancer in the United States. As such, its risks and
benefits are not fully understood.

The scientific aims are to determine the toxicity of Jin Fu Kang/docetaxel combination
treatment in patients with non-small cell lung cancer, to determine whether Jin Fu Kang
alters the pharmacokinetics of docetaxel and to provide preliminary efficacy and survival
data for Jin Fu Kang/docetaxel combination treatment in patients with 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the toxicity of Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer.

Principal Investigator

Naiyer A Rizvi, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

03-010

NCT ID:

NCT00260026

Start Date:

November 2004

Completion Date:

January 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021