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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Jin Fu Kang

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.

• Study Type: Interventional
• Enrollment: 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Naiyer A Rizvi, M.D, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: November 29, 2005
• First Submitted That Met QC Criteria: November 29, 2005
• First Posted (Estimate): December 1, 2005

Study Record Updates

• Last Update Posted (Estimate): January 26, 2007
• Last Update Submitted That Met QC Criteria: January 25, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 03-010