Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)
Recruitment status was Recruiting
The rationale of phase II study of biweekly docetaxel and cisplatin in patients with unresectable NSCLC are follows:
First, the optimal dose and schedule of combination with docetaxel and cisplatin are still controversial (3 weekly versus weekly).
Platinum-based combination chemotherapy improves the survival of patients with advanced non-small cell lung cancer (NSCLC) in the first-line setting.
Combination chemotherapy with docetaxel and cisplatin is one of the standard platinum-based regimens for treating NSCLC. However, usual standard 3 weekly regimen with docetaxel and cisplatin have consistently produced frequent Grade 3-4 neutropenia, and febrile neutropenia.
Although weekly docetaxel and cisplatin is better tolerated than chemotherapy every 3 weeks, especially in the first line setting in terms of myelosuppression, the optimal dose and schedule for administration of the two drugs has not yet been determined.
Both 3-weekly docetaxel plus cisplatin and weekly schedule showed similar response rates but had different toxicity profiles. The most frequent grade 3 or 4 toxicities were neutropenia in the 3 weekly schedule and fatigue or asthenia in the weekly schedule.
Second, docetaxel and cisplatin have different action and mechanism. Docetaxel showed characteristic early bone marrow suppression 5-7 days after infusion compared with usual 14 days after infusion of cisplatin. Thus, nadir period is not overlapped when the investigators administered both drugs concomittantly.
Third, there are many feasible reports of biweekly administration of docetaxel in patients with NSCLC, breast cancer, stomach cancer, and ovarian cancer with better safety profiles.
Therefore,the investigators designed this phase II study to evaluate the efficacy and toxicity of biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC and test the hypothesis that biweekly schedule of docetaxel and cisplatin is better tolerated than both standard 3 week and weekly schedule in terms of hematologic (neutropenia) and non-hematologic toxicities (asthenia, interstitial pneumonitis. Additionally the investigators will evaluate polymorphism associated with this study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable Non-small Cell Lung Cancer|
- Response rates confirmed with CT or MRI [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
- Time to Progression and Overall Survival confirmed through follow-up and observation following treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: biweekly schedule
docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Drug: Docetaxel and Cisplatin
see drug information. This drug was already approved by Korean FDA and available in market of Republic of Korea.
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|Contact: Gyeong-Won - Lee, M.D.Ph.D.||82-55-750-8066 ext -||email@example.com|
|Contact: Sun Joo - Kim, M.D.Ph.D.||82-55-750-9250 ext -||firstname.lastname@example.org|
|Korea, Republic of|
|Gyeongsang National University Hospital||Recruiting|
|Jinju, Gyeongsang-Nam-Do, Korea, Republic of, 660-702|
|Principal Investigator: Gyeong-Won Lee, M.D.Ph.D.|
|Principal Investigator:||Gyeong-Won Lee, M.D.Ph.D.||Gyeongsang National University Hospital IRB|