Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)
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: 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 High Risk Patients With Unresectable Non-small Cell Lung Cancer|
- Response Rates Confirmed With CT or MRI [ Time Frame: after every 2 cycles of docetaxel and cisplatin ] [ Designated as safety issue: Yes ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0.
- We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC. [ Time Frame: after every 2 cycles of docetaxel and cisplatin ] [ Designated as safety issue: Yes ]we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)
- Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment [ Time Frame: From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
No Intervention: biweekly schedule
docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Drug: Docetaxel and Cisplatin
splitted administration of docetaxel and cisplatin.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00995761
|Korea, Republic of|
|Gyeongsang National University Hospital|
|Jinju, Gyeongsang-Nam-Do, Korea, Republic of, 660-702|
|Principal Investigator:||Gyeong-Won Lee, M.D.Ph.D.||Gyeongsang National University Hospital IRB|