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Sponsored by: |
Far Eastern Memorial Hospital |
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Information provided by: | Far Eastern Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00270582 |
Primary to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens:
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Taxotere, Cisplatin, Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 58 |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 :
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 :
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.
Contact: CHI HUANG HSIAO, M.D. | 886-2-89667000 ext 2102 | onchsiao@ms28.hinet.net |
Taiwan, Ban-Ciao | |
Chi-Huang Hsiao | Recruiting |
Taipei, Ban-Ciao, Taiwan, 220 | |
Contact: CHI HUANG HSIAO, M.D. 886-2-89667000 ext 2102 onchsiao@ms28.hinet.net |
Principal Investigator: | CHI HUANG HSIAO, M.D. | Far Eastern Memorial Hospital |
Study ID Numbers: | FEMH-94015 |
Study First Received: | December 26, 2005 |
Last Updated: | January 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00270582 |
Health Authority: | Taiwan: Department of Health |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |