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A Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small-Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00270582
Recruitment Status : Unknown
Verified September 2005 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2005
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:

Primary to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens:

  1. weekly docetaxel plus cisplatin followed by gemcitabine and
  2. gemcitabine plus cisplatin followed by weekly docetaxel. Study design:Prospective, multi-center, open-labelled, randomized phase II study.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Taxotere, Cisplatin, Gemcitabine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens:
  2. weekly docetaxel plus cisplatin followed by gemcitabine and
  3. gemcitabine plus cisplatin followed by weekly docetaxel.

Secondary Outcome Measures :
  1. To evaluate the median overall time to treatment failure (TTF).
  2. To evaluate the overall progression free survival (PFS).
  3. To evaluate the overall survival of each arm.
  4. To evaluate the time to treatment failure for first regimen.
  5. To evaluate the progression free survival for first regimen.
  6. To evaluate the response rate for each regimen.
  7. To evaluate the toxicity of each arm.
  8. To evaluate the duration of response.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.

    2. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage IIIB or IV disease, no curative treatment available, candidate for chemotherapy.

    4. Age > 18 years and < 75 years. 5. Performance status WHO performance status 0,1. 6. Previous therapy:

    (a) Chemotherapy: None. (b) Previous radiation therapy : prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.

    7. Unidimentional or bidimentional measurable disease. 8. Life expectancy > 12 weeks. 9. Laboratory requirements :

    1. Hematology: Neutrophils * 1.5 109/l, Platelets * 100 109/l, Hemoglobin > 10 g/dl.
    2. Hepatic function : Total bilirubin < 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL ; except in presence of only bone metastasis and in the absence of any liver disorders. Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
    3. Renal function : Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.

      10.Complete initial lab studies within 2 weeks prior to first infusion, imaging studies within 4 weeks prior to first infusion.

      11.Patients must be accessible for treatment and follow-up.

      Exclusion Criteria:

  • 1.Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.

    2. Symptomatic central nervous system metastasis, patients with asymptomatic brain metastasis can be accepted if the tumor is irradiated and do not need steroid to control symptom.

    3. Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria.

    4. Other serious illness or medical condition :

    1. congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.
    2. history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
    3. active uncontrolled infection.
    4. contraindication for the use of corticosteroids. 5. Past or current history of neoplasm other than non small cell lung cancer, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix within 5 years.

      6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.

      7. Concurrent treatment with any other anti-cancer therapy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270582


Contacts
Contact: CHI HUANG HSIAO, M.D. 886-2-89667000 ext 2102 onchsiao@ms28.hinet.net

Locations
Taiwan
Chi-Huang Hsiao Recruiting
Taipei, Ban-Ciao, Taiwan, 220
Contact: CHI HUANG HSIAO, M.D.    886-2-89667000 ext 2102    onchsiao@ms28.hinet.net   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: CHI HUANG HSIAO, M.D. Far Eastern Memorial Hospital

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00270582     History of Changes
Other Study ID Numbers: FEMH-94015
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: September 2005

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators