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

University of Rochester1 site in 1 country41 target enrollmentJune 1998

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsPaclitaxel Radiation Therapy

DrugsPaclitaxel

Overview

Phase: Phase 1
Intervention: Paclitaxel
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: University of Rochester
Enrollment: 41
Locations: 1
Primary Endpoint: Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1998

End Date

December 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Yuhchyau Chen

Principal Investigator

University of Rochester

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.
•Karnofsky performance status \>
•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

Arms & Interventions

1st dose cohort 15mg/m2 taxol plus RT

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

Intervention: Paclitaxel