Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer

Study Overview
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Brief Summary
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A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.

Official Title
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A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Paclitaxel
* Procedure: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed lung cancer, excluding small cell carcinoma Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998 The primary tumor must be radiographically measurable. Age > 18. Karnofsky performance status > 70. FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually > 800 ml Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min. Laboratory values must be obtained < 3 weeks prior to registration. A signed informed consent. Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy. Exclusion Criteria: Patients with medical contraindication to chemotherapy or radiotherapy. Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Women who are pregnant. Patients with small cell carcinoma or mesothelioma

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st dose cohort 15mg/m2 taxol plus RT<br>15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible | Drug: Paclitaxel<br>* On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.<br>Procedure: Radiation Therapy<br>* Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible<br>|
| Experimental: 2nd dose cohort20 mg/m2 taxol plus daily RT<br> | Drug: Paclitaxel<br>* On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.<br>Procedure: Radiation Therapy<br>* Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible<br>|
| Experimental: 3rd Dose Cohort --25mg/m2 taxol plus RT<br> | Drug: Paclitaxel<br>* On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.<br>Procedure: Radiation Therapy<br>* Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible<br>|
| Experimental: Phase II Arm --20mg/m2 taxol plus RT<br> | Drug: Paclitaxel<br>* On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.<br>Procedure: Radiation Therapy<br>* Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Survival | This is median survival for all subjects enrolled. | 86 months |