Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 1998 |
| End Date: | December 2012 |
A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers
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.
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.
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
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