Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00173888

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2012-11-30

Brief Summary

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。

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Combination, Chemotherapy,non-small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Docetaxel, Cisplatin

Intervention Type: DRUG

docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15

B

Group Type: ACTIVE_COMPARATOR

Gemcitabine, Cisplatin

Intervention Type: DRUG

gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15

Interventions

Docetaxel, Cisplatin

docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15

Intervention Type: DRUG

Gemcitabine, Cisplatin

gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Hsin Yang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology , National Taiwan University Hospital

Ann-Lii Cheng, M.D.,Ph.D.

Role: STUDY_CHAIR

Department of Oncology , National Taiwan University Hospital

Locations

Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

920303

Identifier Type: -

Identifier Source: org_study_id