Clinical trial NCT00178256: Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
Official title: A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
timeFrame: 5 years
Secondary outcomes:
measure: Median Survival
timeFrame: 86 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Yuhchyau Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Pandya K, Keng PC, Johnstone D, Li J, Lee YJ, Smudzin T, Okunieff P. Phase I/II clinical study of pulsed paclitaxel radiosensitization for thoracic malignancy: a therapeutic approach on the basis of preclinical research of human cancer cell lines. Clin Cancer Res. 2003 Mar;9(3):969-75.