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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Jin Fu Kang
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine whether Jin Fu Kang alters the pharmacokinetics of docetaxel.
To provide preliminary efficacy and survival data for Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer.

Full Information

First Posted
November 29, 2005
Last Updated
January 25, 2007
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00260026
Brief Title
Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer
Official Title
Safety and Pharmacokinetic Study of Jin Fu Kang In Combination With Docetaxel for Patients With Previously Treated Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Jin Fu Kang
Primary Outcome Measure Information:
Title
To determine the toxicity of Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer.
Secondary Outcome Measure Information:
Title
To determine whether Jin Fu Kang alters the pharmacokinetics of docetaxel.
Title
To provide preliminary efficacy and survival data for Jin Fu Kang / docetaxel combination treatment in patients with previously treated non-small cell lung cancer.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiyer A Rizvi, M.D
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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