Phase 2 N=41 Treatment

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

Carcinoma, Non-Small-Cell Lung

Bottom Line

View on ClinicalTrials.gov: NCT00178256 ↗

Enrolled (actual)

Serious AEs

17.1%

Results posted

Jan 2014

Primary outcome: Primary: Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. — 20; 28.6; 33.3 Percentage subj w dose limiting toxicity

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Paclitaxel (Drug); Radiation Therapy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.	20; 28.6; 33.3	—
SECONDARY Median Survival	10.2	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00178256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.