Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Procedure: Radiation Therapy
- Registration Number
- NCT00178256
- Lead Sponsor
- University of Rochester
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1st dose cohort 15mg/m2 taxol plus RT Paclitaxel 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 3rd Dose Cohort --25mg/m2 taxol plus RT Radiation Therapy - 1st dose cohort 15mg/m2 taxol plus RT Radiation Therapy 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 2nd dose cohort20 mg/m2 taxol plus daily RT Paclitaxel - 2nd dose cohort20 mg/m2 taxol plus daily RT Radiation Therapy - 3rd Dose Cohort --25mg/m2 taxol plus RT Paclitaxel - Phase II Arm --20mg/m2 taxol plus RT Paclitaxel - Phase II Arm --20mg/m2 taxol plus RT Radiation Therapy -
- Primary Outcome Measures
Name Time Method Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. 5 years
- Secondary Outcome Measures
Name Time Method Median Survival 86 months This is median survival for all subjects enrolled.
Trial Locations
- Locations (1)
University of Rochester, Dept. Radiation Oncology
🇺🇸Rochester, New York, United States