Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.
All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance. The target enrollment is 45 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Duke University Medical Center
Durham, North Carolina, United States
Induction Response
Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Time frame: Between 2 and 3 weeks after induction
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Time frame: at the end of the study, estimated 2.5 years
Number of Grade III/IV Hematologic Adverse Events
Time frame: During induction chemotherapy, approximately 6 weeks
Number of Grade III/IV Non-hematologic Adverse Events
Time frame: During induction chemotherapy, approximately 6 weeks
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Time frame: During induction, approximately 6 weeks
Overall Survival
Time frame: Approximately 10 years
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