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

NCT00260026 | Completed Phase 2

• 1 other identifier: 03-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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.

Interventions

Docetaxel DRUG

Jin Fu Kang DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Naiyer A Rizvi, M.D

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 1, 2004
• Study Completion: January 1, 2007
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

US (1)