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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Keywords

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Jin Fu Kang

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Naiyer A Rizvi, M.D

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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03-010

Identifier Type: -

Identifier Source: org_study_id