Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
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
Hematopoietic:
- Platelets ≥ 100 K/mm3
- Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN.
- Alanine transaminase (ALT) ≤ 2.5 x ULN.
- Total bilirubin ≤ 1.5 x ULN
Renal:
- Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
- No significant history of cardiac disease. Must not have unstable angina (anginal
symptoms at rest).
Pulmonary:
- 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
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