Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - patients who were= 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were < 65 years of age and they had an ECOG PS 2 - histologically confirmed non-small cell carcinoma - stages IIIB-IV disease - adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count =1,500/mm3, and platelet count =100,000/mm3), renal function (serum creatinine =1.5 mg/dL), and liver function (total bilirubin =1.5 mg/dL and serum transaminase level less than twice the upper limit of normal) - at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 Exclusion Criteria: - Active infection - Prior chemotherapy, radiotherapy or surgery for their disease, - A history of myocardial infarction in the last 3 months before entry to the study - Uncontrolled congestive heart failure or hypertension - Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer - All the patients provided written informed consent before they entered the study |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gyeongsang National University Hospital | Jinju | Gyeongsang-Nam-Do |
Lead Sponsor | Collaborator |
---|---|
Gyeongsang National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rates Confirmed With CT or MRI | 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. |
after every 2 cycles of docetaxel and cisplatin | Yes |
Primary | 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. | 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) | after every 2 cycles of docetaxel and cisplatin | Yes |
Secondary | Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment | 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 | Yes |
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