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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00173888

Collaborator

(none)

Enrollment

Location

Arms

112.1

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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。

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Docetaxel, Cisplatin Drug: Gemcitabine, Cisplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens. [2003~2009]

Secondary Outcome Measures

To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response [2003~2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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