Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
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Purpose
The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: Docetaxel, Cisplatin Drug: Gemcitabine, Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer |
- The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens. [ Time Frame: 2003~2009 ] [ Designated as safety issue: No ]
- To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response [ Time Frame: 2003~2009 ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | July 2003 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Docetaxel, Cisplatin
docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
|
| Active Comparator: B |
Drug: Gemcitabine, Cisplatin
gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
|
Detailed Description:
Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.
Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice.
Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
- Age > 18 years and < 75 years
- WHO PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 10g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
- Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.
- Life expectancy > 12 weeks
Exclusion Criteria:
- Pregnant, or lactating patients
- Known clinical brain or leptomeningeal involvement
- Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria
- CHF, angina or arrhythmias
- History of significant neurological or psychiatric disorders
- Active uncontrolled infection
- Contraindication for the use of corticosteroids
- Concurrent treatment with other experimental drugs within 30 days prior to study entry
- Concurrent treatment with any other anti-cancer therapy
Contacts and Locations| Taiwan | |
| Department of Oncology, National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Principal Investigator: | Chih-Hsin Yang, M.D.,Ph.D. | Department of Oncology , National Taiwan University Hospital |
| Study Chair: | Ann-Lii Cheng, M.D.,Ph.D. | Department of Oncology , National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00173888 History of Changes |
| Other Study ID Numbers: | 920303 |
| Study First Received: | September 8, 2005 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Combination, Chemotherapy,non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013