Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Detailed Description
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Upon determination of eligibility, patients will receive: Pre-operative Docetaxel Gemcitabine Post-operative Docetaxel Carboplatin Radiation Therapy Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Official Title
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Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Gemcitabine
* Drug: Carboplatin
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically confirmed non-small cell lung cancer Must be operable candidate Clinical stage IB, II, and select III non-small cell lung cancer are eligible Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Must be > 18 years of age Adequate bone marrow, liver or kidney No previous chemotherapy or radiation therapy for non-small cell lung cancer Moderate to severe peripheral neuropathy Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Stage IV disease History of prior malignancy within five years Women who are pregnant or breast-feeding Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered | Drug: Docetaxel<br>* 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles<br>* Other names: Taxotere;Drug: Gemcitabine<br>* 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles<br>* Other names: Gemzar;Drug: Carboplatin<br>* AUC = 1.5 weekly x 7<br>* Other names: Paraplatin;Radiation: Radiation<br>* To 63 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response Rate | A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause. | 19 months | 
| Overall Response Rate (ORR) | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | 18 months | 
| Overall Survival (OS) | Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death. | 18 months |