Phase I Study of Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer (NSCLC) (Stage I to IIIA)
This is a study of chemoradiation for patient with inoperable non small cell lung cancer
with poor pulmonary function. These patients have usually very limited treatment options
because of the compromised lung function. Chemoradiation is usually superior to radiation
alone, but has not been extensively tested in this patient population. Topotecan is a drug
approved for lung cancer that has synergistic activity with radiation. The study will
determine what is the safest dose of topotecan to use with radiation in this patient
population
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
Yes
Dennie Jones, MD
Principal Investigator
University of New Mexico
United States: Institutional Review Board
INST 0529C
NCT00322751
April 2006
November 2009
Name | Location |
---|---|
University of New Mexico | Albuquerque, New Mexico 87131 |