A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
OUTLINE: This is a multi-center study.
- Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes
on Day 1 of a 21-day cycle x 3 cycles
- Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy
must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary
tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5
fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
- Platelets ≥ 100 K/mm3
- Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
- Aspartate transaminase (AST) ≤ 2.5 x ULN.
- Alanine transaminase (ALT) ≤ 2.5 x ULN.
- Total bilirubin ≤ 1.5 x ULN
- Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
- No significant history of cardiac disease. Must not have unstable angina (anginal
symptoms at rest).
- Forced expiratory volume in 1 second (FEV1) greater than 1L
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation
Nasser Hanna, M.D.
Hoosier Oncology Group
United States: Institutional Review Board
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|Providence Portland Medical Center||Portland, Oregon 97213-3635|
|Northwestern University Feinberg School of Medicine||Chicago, Illinois 60611|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Cancer Care Center Of Southern Indiana||Bloomington, Indiana 47403|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Providence Medical Group||Terre Haute, Indiana 47802|
|Community Regional Cancer Center||Indianapolis, Indiana 46256|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|
|Hematology Oncology Associates S.J., P.A.||Mt. Holly, New Jersey 08060|
|Pennsylvania Oncology-Hematology Associates||Philadelphia, Pennsylvania 19106|
|Fox Chase Cancer Center Extramural Research Program||Rockledge, Pennsylvania 19046|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|
|IN Onc/Hem Associates||Indianapolis, Indiana 46202|
|Monroe Medical Associates||Munster, Indiana 46321|
|NorthShore University Health System - Kellogg Cancer Center||Evanston, Illinois 60201|