Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Study Overview
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Brief Summary
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This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Detailed Description
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OBJECTIVES Primary Overall survival Tumor response using RECIST criteria Secondary Determine the toxicity of the proposed treatment in this patient population. Progression free survival Locoregional control Distant failure STUDY DESIGN Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer. Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination. Outcome Measures Primary Outcome Measures Overall survival Tumor response using RECIST criteria Secondary Outcome Measures Locoregional control Distant Failure Progression free survival

Official Title
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Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Taxol (paclitaxel)
* Procedure: Radiotherapy
* Drug: Carboplatin
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion. Patients will be included in the study based on the following criteria: Patients must be older than 18 years old. Patients must have a Zubrod performance status of 0 to 2 Patients with adequate bone marrow function Patients with adequate renal function Patients with adequate hepatic function Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception. Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation. Patients who have signed an approved informed consent and authorization permitting release of personal health information. Exclusion Criteria: Disease-Specific Exclusions Superior sulcus tumors Atelectasis or obstructive pneumonitis of the entire lung Malignant pleural effusion General Medical Exclusions Surgical candidates Patients who are pregnant at the time of diagnosis Serious concomitant systemic disorders incompatible with the study Inability to comply with study and/or follow-up procedures Life expectancy of less than 12 weeks Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study Patients with septicemia or severe infection. Patients who have circumstances that will not permit completion of this study or the required follow-up Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel

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

| Intervention/Treatment |
| --- |
|Drug: Taxol (paclitaxel)|paclitaxel 15mg/m2 Q am on Mon/Wed/Fri|
|Procedure: Radiotherapy|Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before. Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5|
|Drug: Carboplatin|Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9|
|Drug: Gemcitabine|Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response using RECIST criteria |  | 12/31/2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control |  | 12/31/2014 | 
| Distant failure |  | 12/31/2014 | 
| Progression free survival |  | 12/31/2014 |